BD Nokor 305213Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00382903052134), received between Sep 23, 2020 and Apr 8, 2024 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NO ADDITIONAL INFORMATION RECEIVED MATERIAL #:305213 BATCH#: 3158878. IT WAS REPORTED BY CUSTOMER THAT BLACK PARTICLES FOUND. VERBATIM: COMPLAINT RECEIVED. PRODUCTCOMPLAINT-MDS . FACILITY: (B)(6) MED. ADDRESS: (B)(6). CONTACT: (B)(6). EMAIL: (B)(6). PHONE: (B)(6). CONTACT: (B)(6). EMAIL: (B)(6). PHONE: (B)(6). ISSUE: BLACK PARTICLES FOUND. REF 305213, LOT 3158878. PT HARM: NO, SAMPLES: YES , PLEASE CC PURCHASING DEPT AS WELL IN ALL COMMUNICATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19058441 ↗
• MalfunctionMar 25, 2021Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT A NEEDLE VENTED NOKOR 16X1 TW HAD MOLDING DEFECTS WITH SHARP PROTRUSIONS BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT PRODUCT RECEIVED WITH FLASHING. PER ATTACHED EMAIL: WE RECEIVE A SHIPMENT FOR ITEM # 305213 (BUSSE # 5032A) WITH FLASHING. I BELIEVE THIS IS THE THIRD TIME WE HAVE RECEIVE THIS ITEM WITH THE SAME ISSUE. WE WOULD LIKE THIS RETURN. PLEASE SEE IF YOU CAN PROVIDE A RGA NUMBER FOR THIS."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11572514 ↗
• MalfunctionDec 7, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD FOREIGN MATTER ON THE NEEDLE. THIS OCCURRED ON 2 OCCASIONS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230. IT WAS REPORTED THAT FLASHING WAS OBSERVED ON THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10961875 ↗
• MalfunctionNov 18, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230 IT WAS REPORTED THAT THERE WAS FLASHING AND ANGEL HAIR.

  Patient problems: No Patient Involvement

  MAUDE report 10865146 ↗
• MalfunctionNov 11, 2020Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT THE NEEDLE VENTED NOKOR 16X1 TW EXPERIENCED FOREIGN MATTER CONTAMINATION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH NO.: 0143230. WE RECEIVED AGAIN A REJECTION FOR THIS PART: PO (B)(4) (REPLACEMENT ORDER) - PART# 5032A (305213) - R094420 ¿ LOT# 0143230 REASON: FLASHING AND ANGEL HAIR. ALL THE 5 SHIPMENTS RECEIVED HAD TO BE RETURNED TO THIS MATTER AND THIS IS A DIFFERENT LOT NUMBER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10825033 ↗
• MalfunctionOct 20, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT 1000 BD NEEDLE VENTED NOKOR 16X1 TW WERE FOUND TO BE DAMAGED/DEFORMED BEFORE USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTED: "IT WAS REPORTED THAT 1 CASE WERE FOUND WITH FLASHING NEEDLES. PER ATTACHED EMAIL: UNFORTUNATELY WE RECEIVED ANOTHER REJECTION FOR BD# 305213 ¿ BUSSE#5032A THAT CAME IN UNDER PO 848361. 1 CASE = 1000 NEEDLES LOT# 9322472 (SAME LOT AS THE OTHER 2 REJECTIONS). REASON: NEEDLES WERE FOUND WITH FLASHING."

  Patient problems: No Patient Involvement

  MAUDE report 10705004 ↗
• MalfunctionSep 23, 2020Break; Leak/Splash; Break; Leak/Splash

  IT WAS REPORTED THAT NEEDLE VENTED NOKOR 16X1 TW HAD A MOLDING DEFECT. THIS OCCURRED ON 1000 OCCASIONS BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305213 BATCH; NO.: 9322472. IT WAS REPORTED THAT NEEDLES WERE FOUND WITH FLASHING.

  Patient problems: No Patient Involvement

  MAUDE report 10571370 ↗