PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY

Report

Report Number: 2243072-2020-00600
Event Type: Malfunction
Date Received: April 13, 2020
Date of Event: March 23, 2020
Report Date: June 15, 2020
Manufacturer: BECTON DICKINSON AND CO.
Product Code: FMI
PMA / PMN Number: K162516
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

THE EVENT DESCRIPTION, MEDICAL DEVICE BRAND NAME, COMMON DEVICE NAME, MEDICAL DEVICE TYPE, DEVICE EXPIRATION DATE, DEVICE MANUFACTURE DATE, UNIQUE IDENTIFIER NUMBER, PMA/510(K)#, AND DEVICE MANUFACTURE DATE HAVE BEEN UPDATED. THE FOLLOWING INFORMATION HAS BEEN UPDATED: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. CONSUMER REPORTED PEN NEEDLE CLOG DURING PRIMING, STATED THAT SHE RECEIVED A SAMPLE PACK OF 8 NEEDLES FROM HER DOCTOR. CONSUMER WAS NOT ABLE TO LOCATE THE CATALOG NUMBER. DATE OF EVENT: UNKNOWN. MEDICAL DEVICE BRAND NAME: PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY. COMMON DEVICE NAME: HYPODERMIC NEEDLE SINGLE LUMEN. MEDICAL DEVICE MANUFACTURER: DUN LAOGHAIRE, BECTON DICKINSON AND CO. MEDICAL DEVICE TYPE: FMI. MEDICAL DEVICE CATALOG #: 320432. MEDICAL DEVICE LOT #: 8204685. MEDICAL DEVICE EXPIRATION DATE: 2023-07-31. UNIQUE IDENTIFIER (UDI) #: (B)(4). MANUFACTURING LOCATION: DUN LAOGHAIRE, BECTON DICKINSON AND CO. PMA/510(K)#: K162516. DEVICE MANUFACTURE DATE: (B)(6) 2018.

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 4/22/2020. H.6. INVESTIGATION: CUSTOMER RETURNED FOUR (4) USED 32GX4MM BD PEN NEEDLES FROM A SAMPLE PACK FROM LOT 8204685. CONSUMER REPORTED THAT PEN NEEDLE WAS CLOGGED. THE CUSTOMER RETURNED THE FOUR PEN NEEDLES IN A SAMPLE PACK FROM CATALOG #320540, HOWEVER, AS PER SUSTAINING ENGINEER: CATALOG #320432 IS BULK PRODUCT (LOOSE ASSEMBLIES IN A LINER) THAT IS MANUFACTURED AND BULK PACKAGED BY DUN LAOGHAIRE. IT IS THEN RE-PACKAGED INTO CATALOG #320540 BY RR DONNELLY. ALL FOUR RETURNED PEN NEEDLES WERE EXAMINED, AND THE FOLLOWING WAS OBSERVED: TWO PEN NEEDLES HAD BENT NON-PATIENT END (NPE) CANNULAS TWO PEN NEEDLES HAD STRAIGHT NPE CANNULAS.. THE TWO SAMPLES WITH STRAIGHT NPE CANNULAS WERE TESTED FOR FLOW USING A TEST PEN INJECTOR: BOTH SAMPLES WERE ABLE TO EXPEL PROPERLY. NO EVIDENCE OF MANUFACTURING DEFECT WAS OBSERVED ON THE FOUR RETURNED SAMPLES. THE BENT NPE CANNULAS WOULD BE THE CAUSE FOR NO FLOW THROUGH THE PEN NEEDLES, HENCE, THE CUSTOMER WOULD THINK THE PEN NEEDLES WERE CLOGGED (AS REPORTED). SINCE ALL FOUR SAMPLES WERE RETURNED AFTER USE, AND NO MANUFACTURING DEFECTS WERE OBSERVED, THE PROBABLE CAUSE OF THE BENT NPE CANNULAS IS USER ERROR WHEN ATTACHING THE PEN NEEDLES TO A PEN INJECTOR. A LOT HISTORY REVIEW WAS CARRIED OUT AND NO RELATED NON CONFORMANCES WERE RAISED IN ASSOCIATION WITH THIS PACKAGED LOT CONCLUDING ALL INSPECTIONS WERE PERFORMED AS PER THE APPLICABLE OPERATIONS AND MET QC SPECIFICATIONS. THE POSSIBLE ROOT CAUSE FOR THIS ISSUE IS: USER ERROR. NO EVIDENCE OF MANUFACTURING RELATED ISSUES WERE OBSERVED ON THE RETURNED SAMPLES. IT IS BD¿S EXPERIENCE THAT THE NON-PATIENT END BREAKAGE AND BENDING IS DIRECTLY ASSOCIATED WITH THE PLACING OF THE NEEDLE ONTO THE PEN DEVICE BY THE USER. IF THE NON-PATIENT END OF THE NEEDLE IS NOT PLACED CENTRALLY TO THE PEN DEVICE, THEN INSTEAD OF THE NON-PATIENT END OF THE NEEDLE PIERCING THE RUBBER SEPTUM OF THE VIAL, IT HITS HARD MATERIAL AND CAN BE BENT/BROKEN WHEN FITTED TO THE PEN. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN, BATCH NO. UNKNOWN. CONSUMER REPORTED PEN NEEDLE CLOG DURING PRIMING, STATED THAT SHE RECEIVED A SAMPLE PACK OF 8 NEEDLES FROM HER DOCTOR. CONSUMER WAS NOT ABLE TO LOCATE THE CATALOG NUMBER. DATE OF EVENT: UNKNOWN.

Description of Event or Problem · 0

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN CONSUMER REPORTED PEN NEEDLE CLOG DURING PRIMING, STATED THAT SHE RECEIVED A SAMPLE PACK OF 8 NEEDLES FROM HER DOCTOR. CONSUMER WAS NOT ABLE TO LOCATE THE CATALOG NUMBER. DATE OF EVENT: UNKNOWN.

Additional Manufacturer Narrative · 1

DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.

Description of Event or Problem · 1

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF AN UNSPECIFIED BD PEN NEEDLE EXPERIENCED AN INABILITY TO DELIVER INSULIN/MEDICATION AND WAS UNABLE OR DIFFICULT TO PRIME. PRODUCT DEFECTS WERE NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. UNKNOWN BATCH NO. UNKNOWN. CONSUMER REPORTED PEN NEEDLE CLOG DURING PRIMING, STATED THAT SHE RECEIVED A SAMPLE PACK OF 8 NEEDLES FROM HER DOCTOR. CONSUMER WAS NOT ABLE TO LOCATE THE CATALOG NUMBER. DATE OF EVENT: UNKNOWN.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
419467	PEN NDL 32G 4MM 5B XTW BULK US W/EXPIRY	HYPODERMIC NEEDLE SINGLE LUMEN	FMI	BECTON DICKINSON AND CO.		8204685

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other