BD ULTRA FINE PEN NEEDLES

Report

Report Number: 9616656-2020-00365
Event Type: Malfunction
Date Received: April 27, 2020
Date of Event: April 6, 2020
Report Date: June 11, 2020
Manufacturer: BECTON DICKINSON AND CO.
Product Code: FMI
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: FIVE PHOTOS OF 32G X 4MM PEN NEEDLES WERE RETURNED FROM AN LOT. NO. 8233897, CAT. NO. 320136. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND NO ISSUES WERE OBSERVED. 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. COMPLAINT COULD NOT BE CONFIRMED AND THE ROOT CAUSE IS UNDETERMINED.

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8233897. D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023. H.4. DEVICE MANUFACTURE DATE: 8/21/2018. D.4. MEDICAL DEVICE LOT #: 8149860. D.4. MEDICAL DEVICE EXPIRATION DATE: 5/31/2023. H.4. DEVICE MANUFACTURE DATE: 5/29/2018. D.4. MEDICAL DEVICE LOT #: 8282901. D.4. MEDICAL DEVICE EXPIRATION DATE: 10/31/2023. H.4. DEVICE MANUFACTURE DATE: 10/9/2018. D.4. MEDICAL DEVICE LOT #: 9079914. D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024. H.4. DEVICE MANUFACTURE DATE: 3/20/2019. D.4. MEDICAL DEVICE LOT #: 9204740. D.4. MEDICAL DEVICE EXPIRATION DATE: 7/31/2024. H.4. DEVICE MANUFACTURE DATE: 7/23/2019. D.4. MEDICAL DEVICE LOT #: 9071870 D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024 H.4. DEVICE MANUFACTURE DATE: 3/12/2020 D.4. MEDICAL DEVICE LOT #: 8247894. D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023. H.4. DEVICE MANUFACTURE DATE: 9/4/2018. D.4. MEDICAL DEVICE LOT #: 7312922. D.4. MEDICAL DEVICE EXPIRATION DATE: 11/30/2022. H.4. DEVICE MANUFACTURE DATE: 11/8/2017. D.4. MEDICAL DEVICE LOT #: 9015895. D.4. MEDICAL DEVICE EXPIRATION DATE: 1/31/2024. H.4. DEVICE MANUFACTURE DATE: 1/15/2019. D.4. MEDICAL DEVICE LOT #: 9079912. D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024. H.4. DEVICE MANUFACTURE DATE: 3/20/2019. D.4. MEDICAL DEVICE LOT #: 9092787=D.4. MEDICAL DEVICE EXPIRATION DATE: 3/31/2024 H.4. DEVICE MANUFACTURE DATE: 4/2/2019 D.4. MEDICAL DEVICE LOT #: 8346591 D.4. MEDICAL DEVICE EXPIRATION DATE: 12/31/2023 H.4. DEVICE MANUFACTURE DATE: 12/12/2018 D.4. MEDICAL DEVICE LOT #: 9226279 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2024 H.4. DEVICE MANUFACTURE DATE: 8/14/2019 D.4. MEDICAL DEVICE LOT #: 8247893 D.4. MEDICAL DEVICE EXPIRATION DATE: 8/31/2023 H.4. DEVICE MANUFACTURE DATE: 9/4/2018 D.10. DEVICE AVAILABLE FOR EVAL?: YES D.10. RETURNED TO MANUFACTURER ON: 6/3/2020 H.6. INVESTIGATION: FIVE PHOTOS OF 32G X 4MM PEN NEEDLES WERE RETURNED FROM AN LOT. NO. 8233897, CAT. NO. 320136. VISUAL EXAMINATION OF THE RETURNED PHOTOS WAS CARRIED OUT AND NO ISSUES WERE OBSERVED. THE FOLLOWING PEN NEEDLE SAMPLES ALONG WITH FIVE PHOTOS WERE RETURNED: FOUR OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.8247894, CAT. NO.320136. ONE OPEN 32G X 4MM PEN NEEDLE SAMPLE WAS RETURNED FROM LOT. NO.8247893, CAT. NO.320136. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9092787, CAT. NO.320136. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.8346591, CAT. NO.320136. THREE OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9079912, CAT. NO.320136. FOUR OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.7312922, CAT. NO.320136. TEN OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9204740, CAT. NO.320136. EIGHT OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9071870, CAT. NO.320136. 11 OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM AN UNKNOWN LOT. NO., CAT. NO.320136. EIGHT OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.8149860, CAT. NO.320136. FOUR OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9015895, CAT. NO.320136. TWENTY TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.8282901, CAT. NO.320136. ELEVEN OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.8233897 CAT. NO.320136. 11 OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9079914 CAT. NO.320136. TWO OPEN 32G X 4MM PEN NEEDLE SAMPLES WERE RETURNED FROM LOT. NO.9226279, CAT. NO.320136. CLOG TESTING WAS CARRIED OUT ON THE 103 OPEN SAMPLES AS PER TP700483 AND NO ISSUES WERE OBSERVED. A LOT HISTORY REVIEW WAS CARRIED OUT ON THE NEWLY REPORTED LOTS 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. H3 OTHER TEXT : SEE H.10.

Description of Event or Problem · 0

IT WAS REPORTED THAT MEDICATION DIDN'T FLOW DURING PRIMING WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRUG DIDN'T COME OUT. THE ISSUE OCCURRED 4-5 TIMES.

Description of Event or Problem · 0

IT WAS REPORTED THAT MEDICATION DIDN'T FLOW DURING PRIMING WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM JAPANESE TO ENGLISH: DRUG DIDN'T COME OUT. THE ISSUE OCCURRED 4-5 TIMES.

Additional Manufacturer Narrative · 1

MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. INITIAL REPORTER PHONE #: 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.

Description of Event or Problem · 1

IT WAS REPORTED THAT MEDICATION DIDN'T FLOW DURING PRIMING WITH A BD ULTRA FINE¿ PEN NEEDLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: DRUG DIDN'T COME OUT. THE ISSUE OCCURRED 4-5 TIMES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
467308	BD ULTRA FINE PEN NEEDLES	HYPODERMIC SINGLE LUMEN NEEDLE	FMI	BECTON DICKINSON AND CO.		SEE H.10

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other