MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEN NDL 31G 5MM; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	320882
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: the complaint is unconfirmed as no photo / samples received.Root cause description: a review was performed for the last 12 months of quality notification.There was no quality notification was raised for the reported non ¿ conformance no abnormality was observed during the production of the reported batch.The investigation was not able to confirm what customer had experienced as no samples or pictures were received for evaluation.Hence, root cause is unable to be determined if samples are received in the future the complaint will be re-opened and re-investigated.Rationale: the complaint will continue to be tracked and monitored.
Event or Problem Description
It was reported that needle did not deliver medication and was bent after injection with a bd pen ndl 31g 5mm.The clog occurred on 8 separate occasions during use, however, the date/time is unknown.The following information was provided by the initial reporter: material no: 320882, batch no: 8078465.It was reported that needle clog during injection and also it was reported that needle was bent after removing from the pen.Additional information provided by consumer: spouse of consumer reported nothing comes out of the pen needle during the injection.Insulin doesn't dispense even after she presses the plunger.Sample-discarded.Occurence-8; incident date-unknown.She does not do the priming.She does the visual test on the needle to see if its straight.She uses new pen needle each time of husbands injection.She does rotate the injection site.Item# 320882; lot# 8078465; expiration date-02-28-2023.She also reported about the bent pen needle after removing it from the pen.Sample discarded.Item# 320882; lot-8078465; expiration date-2023-02-28.Sample discarded.Occurence-unknown; incident-unknown.

• Brand Name: BD PEN NDL 31G 5MM
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8713832
• Report Number: 8041187-2019-00469
• Device Sequence Number: 13958647
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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
• Report Date (Section B): 06/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Catalogue Number: 320882
• Device Lot Number: 8078465
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/19/2019
• 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