FDA Adverse Event Malfunction Summary report: N

BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE

MDR report key: 15958255 · Received December 12, 2022

Report

Report Number: 1920898-2022-00865
Event Type: Malfunction
Date Received: December 12, 2022
Date of Event: November 13, 2022
Report Date: December 30, 2022
Manufacturer: BD MEDICAL - DIABETES CARE
Product Code: FMF
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INITIAL REPORTER PHONE #: (B)(6). A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative · 0

H6: INVESTIGATION SUMMARY: NO SAMPLES (INCLUDING PHOTOS) WERE RETURNED THEREFORE THE COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR BATCH# 1130195. ALL INSPECTIONS AND CHALLENGES WERE PERFORMED PER THE APPLICABLE OPERATIONS QC SPECIFICATION.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE HAS PLASTIC FOREIGN OBJECTS IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: ROUTINE INSPECTION BEFORE USE, FOUND THAT THERE ARE PLASTIC FOREIGN OBJECTS IN THE NEEDLE.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE HAS PLASTIC FOREIGN OBJECTS IN THE NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: ROUTINE INSPECTION BEFORE USE, FOUND THAT THERE ARE PLASTIC FOREIGN OBJECTS IN THE NEEDLE

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2130261	BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE	PISTON SYRINGE	FMF	BD MEDICAL - DIABETES CARE		1130195

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown