BD Sharps Collector 305635Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 00382903056354), received between Nov 21, 2018 and Sep 25, 2023 — classified as 37 malfunctions.

The most frequently reported specific device problem is “Component Missing” (20 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 25, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE 1.0L BD¿ SHARPS COLLECTOR RED WERE MISSING LIDS. THE FOLLOWING WAS TRANSLATED FROM JAPANES TO ENGLISH: THIS REPORT IS ABOUT MISSING LID.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17807489 ↗
• MalfunctionAug 22, 2023Missing Information; Missing Information

  IT WAS REPORTED THAT 2 BD® PHLEBOTOMY SHARPS COLLECTOR LABEL WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT LABEL DISLODGMENT. IT WAS UNKNOWN IF THE PRODUCT LABEL WAS INCORRECTLY ATTACHED OR MELTED DUE TO HIGH TEMPERATURE, BUT THE LABEL WAS DISLODGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17597663 ↗
• MalfunctionJul 17, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS WERE MISSING 9 LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORTED THAT LIDS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17339366 ↗
• MalfunctionMay 22, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT THE 2 BD¿ PHLEBOTOMY SHARPS COLLECTOR WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MISSING LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16981207 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED THAT THE BD¿ PHLEBOTOMY NESTABLE SHARPS COLLECTOR LID WAS UNABLE TO CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOES NOT SHUT WHEN ASSEMBLED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873125 ↗
• MalfunctionMar 1, 2023Component Missing; Component Missing

  IT WAS REPORTED THAT 2 BD¿ PHLEBOTOMY SHARPS COLLECTOR WAS MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT MISSING LIDS OF SHARPS COLLECTOR 1.0L. ACCORDING TO THE CUSTOMER'S REPORT, TWO LIDS WERE FOUND TO BE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16460912 ↗
• MalfunctionFeb 21, 2023Break; Break

  IT WAS REPORTED THAT THE BD¿ PHLEBOTOMY SHARPS CONTAINER LID PORT WAS DAMAGED BY THE PEN NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "AFTER USING THE PEN NEEDLE (CAT#320559), THE USER USED THE NEEDLE PORT OF SHARPS COLLECTOR TO REMOVE THE PEN NEEDLE FROM THE PEN, BUT THE NEEDLE WAS NOT REMOVED PROPERLY FROM THE PEN WITH THE NEEDLE BROKEN AND STAYED WITH THE PEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16415090 ↗
• MalfunctionFeb 16, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE LID DID NOT FIT THE BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "LID ISSUE: THE LID COULD NOT FIT THE BASE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16390328 ↗
• MalfunctionNov 30, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD¿ PHLEBOTOMY SHARPS CONTAINERS WITH NEEDLE PORTS WERE RECEIVED WITHOUT LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE RECEIVED AN EMAIL FROM CX THAT THEY RECEIVED THE ITEM BUT THESE SHARP CONTAINERS DID NOT COME WITH ANY LIDS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15890022 ↗
• MalfunctionNov 28, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT THE BD SHARPS COLL 1QT RED WAS MISSING A LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARP CONTAINERS DID NOT COME WITH ANY LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874998 ↗
• MalfunctionNov 28, 2022Incomplete or Missing Packaging; Incomplete or Missing Packaging

  IT WAS REPORTED THAT 6 BD SHARPS COLL 1QT RED WERE MISSING LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SHARP CONTAINERS DID NOT COME WITH ANY LIDS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15874981 ↗
• MalfunctionNov 11, 2022Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED WHILE USING BD SHARPS COLL 1QT RED THE LID DID NOT FIT PROPERLY. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS IS A REPORT ABOUT A LID ISSUE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE LID DID NOT FIT TO THE BASE. THE USER TRIED WITH SEVERAL LIDS BUT ALL THE TESTED LIDS DID NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15784380 ↗
• MalfunctionSep 27, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ PHLEBOTOMY SHARPS CONTAINER WITH NEEDLE PORTS WAS MISSING ITS LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6): "THIS IS A REPORT ABOUT A MISSING LID OF SHARPS COLLECTOR. ACCORDING TO THE DISTRIBUTOR'S REPORT, ONE LID WAS MISSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15491637 ↗
• MalfunctionJul 14, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT 1 BD SHARPS COLL 1QT RED HAD NO LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THE CUSTOMER REPORT THAT IN A CARTON THAT SHOULD CONTAIN 60 PRODUCTS THERE WERE ONLY 59 LIDS WITH ONE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15021767 ↗
• MalfunctionJun 27, 2022Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE BD¿ PHLEBOTOMY SHARPS COLLECTOR HAS LID THAT IS DIFFICULT TO CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT THE INABILITY TO ASSEMBLE THE LID ONTO THE BASE OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER¿S REPORT, THERE WAS ONE AFFECTED PRODUCT WITH THE LID UNABLE TO BE ASSEMBLED ONTO THE BASE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14831706 ↗
• MalfunctionApr 21, 2022Component Missing; Component Missing

  IT WAS REPORTED WHILE USING BD SHARPS COLLECTOR 1QT RED THE LID WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTED THAT ONE LID OF SC WAS MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14169164 ↗
• MalfunctionMar 24, 2022Missing Information; Missing Information

  IT WAS REPORTED WHEN USING THE BD¿ PHLEBOTOMY SHARPS COLLECTOR, 1 QT WITH NEEDLE PORT THERE WAS NO LABEL OR MISSING LABEL INFORMATION. THIS EVENT OCCURRED WITH 5 COLLECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS NO LABEL ON FIVE PRODUCTS IN A CARTON."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13892095 ↗
• MalfunctionFeb 4, 2022Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD SHARPS COLLECTOR 1QT THERE WAS A MISSING LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ONE LID WAS MISSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13453061 ↗
• MalfunctionFeb 3, 2022Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD SHARPS COLLECTOR 1QT THERE WAS A MISSING LID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "ONE LID WAS MISSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13446575 ↗
• MalfunctionJan 11, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR WAS MISSING A LID. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "ONE LID IS MISSING."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13233217 ↗
• MalfunctionJan 5, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT 2 BD SHARPS COLLECTOR 1QT HAD MISSING LABEL INFORMATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE LABEL WAS NOT AFFIXED PROPERLY AND WAS WRINKLED ONTO TWO PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13170879 ↗
• MalfunctionDec 29, 2021Break; Break

  IT WAS REPORTED THAT BD SHARPS CONTAINER HAD A DIFFICULT TO CLOSE LID WHICH RESULTED IN A NEEDLE STICK INJURY. THERE WAS NO REPORT OF IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: " THE SHARPS COLLECTOR DIDN¿T WORK TO DISPOSE THE UNUSED PRODUCT; WHEN THE NURSE DID RECAPPING WITH BOTH HANDS AFTER SUPPORTING A PATIENT TO INJECT INSULIN, SHE PRICKED HER FINGER ON THE NEEDLE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13114128 ↗
• MalfunctionNov 12, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE BD SHARPS COLL 1QT RED THE LID OR SLIDE LID/CLAMP WAS MISSING. THIS EVENT OCCURRED 12 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THERE WAS A MISSING COMPONENT. THE TOPS OF THE PRODUCT WERE MISSING".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12802887 ↗
• MalfunctionSep 28, 2021Component Missing; Component Missing

  IT WAS REPORTED WHEN USING THE SHARPS COLL 1QT RED THERE WAS LID OR SLIDE LID/CLAMP MISSING. THIS EVENT OCCURRED 2 TIMES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "DURING THE INSPECTION, UPON ARRIVAL, THE DISTRIBUTOR NOTICED THAT TWO LIDS WERE MISSING.".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12544123 ↗
• MalfunctionAug 4, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THERE WAS NO LABEL ON THE SHARPS COLL 1QT RED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE CUSTOMER REPORTED THAT THERE WAS NO LABEL ON THE PACKAGE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12277990 ↗