MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of pen ndl 31g 5mm 90 count mail order only were unable to deliver insulin/medication during use.The following information was provided by the initial reporter: material no: 320882 batch no: 9114903.Consumer reported no insulin flow during injection.Consumer is new to using pen needles, does not re-use.Date of event: unknown.
Event or Problem Description
It was reported that an unspecified number of pen ndl 31g 5mm 90 count mail order only were unable to deliver insulin/medication during use.The following information was provided by the initial reporter: material no: 320882 batch no: 9114903.Consumer reported no insulin flow during injection.Consumer is new to using pen needles, does not re-use.Date of event: unknown.
Additional Manufacturer Narrative
H.6.Investigation summary customer returned three (3) used 31gx5mm bd pen needles from lot 9114903.Consumer reported no insulin flow during injection.All three returned pen needles were examined, and it was observed that two pen needles exhibited a bent non-patient end (npe) cannula, and one pen needle exhibited a broken npe cannula.No evidence of manufacturing defect was observed.The bent and broken 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 three pen needles were returned after use, and no manufacturing defects were observed, the probable cause of the bent and broken npe cannulas is user error when attaching the pen needles to a pen injector.Pen needle dhr batch 9114903 was reviewed.The batch number was built with pen needle assembly line in july 2019.Review of the dhr revealed all required challenges samples and testing was performed per specification in accordance with the in-process sampling plans.No quality notification was raised on past 12 months on similar non-conformance.The possible root cause for this issue is: user error.No evidence of manufacturing related issues were observed on the returned samples.

• Brand Name: PEN NDL 31G 5MM 90 COUNT MAIL ORDER ONLY
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10228201
• Report Number: 8041187-2020-00375
• Device Sequence Number: 594933
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K162516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 8975
• Device Catalogue Number: 320882
• Device Lot Number: 9114903
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2020
• Initial Date Received by Manufacturer: 06/12/2020
• Supplement Date Received by Manufacturer: 06/12/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 08/06/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other