BD Sharps Collector 305488Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00382903054886), received between Nov 30, 2018 and Aug 2, 2023 — classified as 22 malfunctions.

The most frequently reported specific device problem is “Break” (6 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 2, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD 3QT RED SHARPS COLLECTOR THE LID WAS DIFFICULT TO CLOSE. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT A DAMAGED LID. THE CUSTOMER REPORTED THAT THE LID DID NOT SHUT AND WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446901 ↗
• MalfunctionAug 2, 2023Break; Break

  IT WAS REPORTED WHILE USING BD 3QT RED SHARPS COLLECTOR THE LID WAS DAMAGED. THIS OCCURRED 3 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: THIS REPORT IS ABOUT A DAMAGED LID. THE CUSTOMER REPORTED THAT THE LID DID NOT SHUT AND WAS DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17446896 ↗
• MalfunctionJul 31, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT 4 OF THE BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR LID WAS BROKEN AND UNABLE TO CLOSE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: VERBATIM: THE CUSTOMER REPORTED THAT THE PRODUCT LID WAS DAMAGED AND WOULD NOT CLOSE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17429164 ↗
• MalfunctionJun 30, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP WITH PETALS LIDS DID NOT FIT PROPERLY. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: CUSTOMER REPORTED THAT THE LID DID NOT FIT TIGHTLY. DURING PRODUCT CHECK, IT WAS OBSERVED THAT THE LID DID NOT FIT. THE COMPLAINT PRODUCT WAS UNUSABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238339 ↗
• MalfunctionJun 22, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT DURING USE WITH BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR THE LID WOULD NOT CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOES NOT SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17179694 ↗
• MalfunctionMay 18, 2023Fitting Problem; Fitting Problem

  IT WAS REPORTED WHILE USING BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP WITH PETALS THE LID DID NOT PROPERLY FIT. 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 DAMAGED LID OF SHARPS COLLECTOR. THE CUSTOMER REPORTED THAT THE LID DID NOT FIT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16951002 ↗
• MalfunctionMay 4, 2023Break; Break

  IT WAS REPORTED WHILE USING BD¿ MULTIUSE ONE-PIECE SHARPS COLLECTOR HINGE CAP THE LID WAS DAMAGED. THIS OCCURRED TWICE. 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 BROKEN LIDS OF SHARPS COLLECTOR. THE CUSTOMER REPORTED THAT LIDS WERE FOUND TO BE DETACHED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16873315 ↗
• MalfunctionMay 3, 2023Break; Break

  IT WAS REPORTED THAT 2 BD ONE-PIECE SHARPS COLLECTOR LID WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT BROKEN LIDS OF SHARPS COLLECTOR. THE CUSTOMER REPORTED THAT LIDS DID NOT CLOSE, WERE DETACHED, AND HAD BENT MARKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16858200 ↗
• MalfunctionMay 1, 2023Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED WHILE USING BD¿ MULTI-USE ONE-PIECE SHARPS COLLECTOR HINGE CAP WITH PETALS THE LID DID NOT CLOSE PROPERLY. THIS OCCURRED 48 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOES NOT SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16843590 ↗
• MalfunctionFeb 27, 2023Break; Break

  IT WAS REPORTED THAT THE BD¿ SHARPS COLLECTOR HINGE CAP WITH PETALS HAD A BROKEN LID. THIS OCCURRED WITH 6 SHARPS COLLECTORS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE: "THE CUSTOMER REPORTED THAT MULTIPLE LIDS WERE FOUND TO BE BROKEN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16449880 ↗
• MalfunctionFeb 17, 2023Defective Component; Defective Component

  IT WAS REPORTED WHILE USING BD¿ MULTI-USE ONE-PIECE SHARPS COLLECTOR, 3.3 QT, RED THE LID WAS INCORRECTLY ASSEMBLED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT SEPARATION OF THE WHITE LID OF SHARPS CORRECTOR. ACCORDING TO THE CUSTOMER¿S REPORT, THE CUSTOMER RECEIVED THE PRODUCT WITH THE WHITE LID SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16401527 ↗
• MalfunctionJul 29, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE BD¿ MULTI-USE ONE-PIECE SHARPS COLLECTOR LID WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONSUMER CALLED TO REPORT THAT SHE CLOSED THE LID OF HER SHARPS CONTAINER AND COULD NOT RE-OPEN IT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136159 ↗
• MalfunctionAug 3, 2021Material Deformation; Material Deformation

  IT WAS REPORTED THAT SHARPS COLL 3.3QT RED LID CAME OFF. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THIS IS A REPORT ABOUT DETACHMENT OF THE LID OF SHARPS COLLECTOR. ACCORDING TO THE CUSTOMER'S REPORT, THE HCP DISPOSED OF A NEEDLE AND LIFTED THE PRODUCT, AND THE LID THEN CAME OFF AND NEEDLES WERE SCATTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12271801 ↗
• MalfunctionMar 28, 2021Break; Break

  IT WAS REPORTED THAT THE BD SHARPS COLLECTOR 3.3 QT. HINGE CAP WITH PETALS EXPERIENCED A LID THAT WAS DIFFICULT TO CLOSE/WOULD NOT CLOSE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THE LID DOES NOT SHUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11580545 ↗
• MalfunctionSep 15, 2020Device Damaged Prior to Use; Device Markings/Labelling Problem; Device Damaged Prior to Use; Device Markings/Labelling Problem

  IT WAS REPORTED THAT SHARPS COLL 3.3QT RED HAD MISSING LABEL INFORMATION. ADDITIONALLY, IT WAS DAMAGED, BUT STILL OPERABLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE SHARPS CONTAINER WAS DAMAGED AND UNITS WERE MISSING LABELS. VERBATIM: REC'D THIS FROM SATURDAY EVENING FROM D.T AT FISHER CLINICAL REGARDING SHARPS CONTAINER 305488, LOT # 0090001. IS THIS A PRODUCT COMPLAINT OR SERVICE? DO I FORWARD THIS ON TO YOU? DO YOU WANT MORE INFORMATION FIRST? WITHIN FISHER CLINICAL SERVICES, WE HELP OUR COMPANY TO FULFILL ITS MISSION TO ENABLE OUR CUSTOMERS TO MAKE THE WORLD HEALTHIER, CLEANER AND SAFER BY CONTINUOUSLY IMPROVING THE QUALITY OF OUR PRODUCTS AND SERVICES AND BY ENSURING GLOBAL REGULATORY COMPLIANCE. PART OF THIS COMPLIANCE INCLUDES ADHERENCE TO SET STANDARDS WE SET AS A BUSINESS, REGARDING THE DISPOSITION AND USABILITY OF PRODUCT WITHIN OUR CLIENTS' CLINICAL TRIAL SETTINGS. THIS NOTIFICATION IS INTENDED TO ALERT YOU ON SOME QUALITY CONCERNS WE'VE NOTICED AS PART OF OUR POST-RECEIPT PROCESS, AND IS LISTED AS FOLLOWS: PN J9074 (DAMAGE INCLUDING STAINS/SMUDGES, CUTS, SCRATCHES ON INDIVIDUAL UNIT LABELING AND ALSO DAMAGED UNITS WITH NO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10535126 ↗
• MalfunctionFeb 11, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT CRACKED LID WAS FOUND BEFORE USE WITH A SHARPS COLL 3.3QT RED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "BEFORE USE, THE ROOT OF THE LID WAS CRACKED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9695133 ↗
• MalfunctionJan 7, 2020Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE LID DETACHED FROM THE BD¿ SHARPS COLLECTOR HINGE CAP WITH PETALS DURING USE AND THE DISPOSED PRODUCTS CAME OUT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "THE LID DETACHED AND DISPOSED PRODUCTS CAME OUT."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9557794 ↗
• MalfunctionNov 8, 2019Break; Break

  IT WAS REPORTED THAT DEFECTIVE LID WAS FOUND DURING USE WITH A SHARPS COLL 3.3QT RED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "PATIENT USES 305488. SHE CLOSED THE LID AND NOW IT WILL NOT OPEN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9298608 ↗
• MalfunctionAug 15, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT HAS BEEN REPORTED THAT THE SHARPS COLL 3.3QT RED HAS BEEN FOUND EXPERIENCING MOLDING DEFECTS BEFORE USE.THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER:MATERIAL NO. 305488 BATCH NO. UNKNOWNIT WAS REPORTED THE HANDLES ARE SO SHARP THEY CAN BREAK THE SKIN."THE HANDLES ARE SO SHARP THEY CAN BREAK THE SKIN."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8898125 ↗
• MalfunctionMay 6, 2019Difficult to Open or Close

  IT WAS REPORTED THAT A LID MALFUNCTION OCCURRED WITH A SHARPS COLL 3.3QT RED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "THE LID DIDN'T SHUT PROPERLY."

  Patient problems: No Information

  MAUDE report 8584282 ↗
• MalfunctionMar 21, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A SHARPS COLL 3.3QT RED HAD A BROKEN CAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8440530 ↗
• MalfunctionNov 30, 2018Component Missing

  IT WAS REPORTED THAT BD¿ SHARPS COLLECTOR 3.3 QT RED HAD THE WHITE LID THAT WAS TILTED AND REMOVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8121357 ↗