BD Sharps Collector 305604Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00382903056040), received between Feb 4, 2019 and Mar 26, 2024 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Component Missing” (4 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2024Break; Defective Component; Break; Defective Component

  IT WAS REPORTED THAT BD SHARPS DISPOSAL LID WAS DIFFICULT TO CLOSE THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER WITH THE FOLLOWING VERBATIM: THE SHARPS COLLECTORS WILL NOT CLOSE CORRECTLY WHICH IS A SAFETY HAZARD. OUR INFUSION NURSES ARE REPORTING THAT IT IS MUCH MORE DIFFICULT TO CLOSE/SECURE THE LIDS OF THE YELLOW BINS, COMPARED TO BEFORE. THEY HAVE TO SNAP THEM ON, AND THEY ARE REPORTING IT IS HARDER TO DO. EVS PICKS THESE BINS UP, WHEN THEY ARE ¾ FULL, IN THE END OF THE DAY, AND WE HAD AT LEAST ONE INSTANCE, WHEN THE BIN¿S LID WAS NOT FULLY SECURED, AND THE TRACE CHEMOTHERAPY SPILLED OUT. SO THERE ARE POTENTIAL ERGONOMICS ISSUES, AND SAFETY ISSUE FOR BOTH INFUSION AND EVS TEAM. PRODUCT#: 305604.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18976667 ↗
• MalfunctionMar 25, 2024Break; Break

  MATERIAL #:305604, BATCH#:UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE LIDS ARE NOT CLOSING/LOCKING CORRECTLY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PLEASE BE ADVISE OUR CUSTOMER IS REPORTING A PRODUCT COMPLAINT FOR ITEM 305604. THE LIDS ARE NOT CLOSING/LOCKING CORRECTLY. BELOW IS A SCREENSHOT OF THE PHOTOS PROVIDED BY THE CUSTOMER. ARE RETURNS NEEDED FOR FURTHER RESEARCH? ONE OF OUR PO'S THE PRODUCT WAS ORDERED BY IS 4531929349.

  Patient problems: Insufficient Information

  MAUDE report 18968856 ↗
• MalfunctionOct 6, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE CHEMO 9GAL LID WAS MISSING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LIDS WERE MISSING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12586569 ↗
• MalfunctionMar 29, 2021Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE SHARPS COLL SLIDE CLOSE CHEMO 9GAL EXPERIENCED A MISSING ABSORBING PAD. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCORDING TO THE CUSTOMER'S REPORT, THERE WAS NO ABSORBENT PAD.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11586710 ↗
• MalfunctionJan 6, 2021Component Missing; Component Missing

  IT WAS REPORTED THAT 10 BD¿ CHEMOTHERAPY SHARPS COLLECTORS WITH SLIDE TOP AND GASKET WERE RECEIVED WITHOUT LIDS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER RECEIVED 10 CHEMO WASTE BINS WITHOUT LIDS."

  Patient problems: No Patient Involvement

  MAUDE report 11122148 ↗
• MalfunctionSep 10, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE CHEMO 9GAL WAS MISSING THE ABSORBENT PAD. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INSPECTION AT A HOSPITAL DEPARTMENT, IT WAS FOUND THAT THERE WAS NO ABSORBENT PAD.

  Patient problems: No Patient Involvement

  MAUDE report 10515706 ↗
• MalfunctionAug 5, 2020Component Missing; Component Missing

  IT WAS REPORTED THAT PRIOR TO USE THE LIDS WERE DISCOVERED TO BE MISSING WITH 8 BD SHARPS COLL SLIDE CLOSE CHEMO 9GAL. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE LIDS WERE MISSING.

  Patient problems: No Patient Involvement

  MAUDE report 10370373 ↗
• MalfunctionAug 5, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET WAS MISSING THE ABSORBING PAD PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(4) TO ENGLISH: "DURING INSPECTION AT SPD, IT WAS FOUND THAT THERE WAS NO ABSORBENT PAD."

  Patient problems: No Patient Involvement

  MAUDE report 10370356 ↗
• MalfunctionDec 19, 2019Component Missing; Component Missing

  IT WAS REPORTED THAT SHARPS COLL SLIDE CLOSE CHEMO 9GAL WAS MISSING THE LID. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305604 BATCH NO.: UNKNOWN IT WAS REPORTED A CASE WAS RECEIVED WITHOUT LIDS. PER EMAIL: WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. PLEASE, RESPOND ACCORDINGLY WITH THE RMA NUMBER, IF NECESSARY, AND THE DISPOSITION OF THE CUSTOMER'S CONCERN. PLEASE CONTACT THE CUSTOMER AND CC ME ON ANY FUTURE COMMUNICATION. INJURIES OR ADVERSE EVENT: NO ARE ANY SAMPLES AVAILABLE FOR RETURN? YES REPORTED ISSUE: CUSTOMER RECEIVING 1 CS WITHOUT LIDS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9495820 ↗
• MalfunctionMay 16, 2019Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET LID WAS FOUND CRACKED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: "BEFORE USE, THE LID WAS CRACKED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8616518 ↗
• MalfunctionFeb 4, 2019Misassembled

  IT WAS REPORTED THAT THE LID ON THE BD¿ CHEMOTHERAPY SHARPS COLLECTOR SLIDE TOP WITH GASKET WAS INSTALLED UPSIDE-DOWN.

  Patient problems: No Information

  MAUDE report 8302344 ↗