MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD ULTRA-FINE¿ INSULIN PEN NEEDLE; 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	04/02/2019
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.
Event or Problem Description
It was reported that the bd ultra-fine insulin pen needle jammed during the injection and during priming.The following information was provided by the initial reporter: "consumer reported needle clog during injection, stated that the needle jams when doing injection and sometimes during priming.".
Additional Manufacturer Narrative
H.6.Investigation: customer returned (7) 31g x 5mm bd pen needles without tear drop labels attached.Consumer reported needle clog during injection, stated that the needle jams when doing injection and sometimes during priming.All 7 returned samples were examined and all 7 exhibited good non-patient end and patient end cannulas.All 7 samples were then tested for flow using a test pen injector, and all 7 passed, therefore the alleged defects (clog & difficult/unable to operate) could not be confirmed.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.Root cause cannot be determined at this time as the issues are unconfirmed.
Event or Problem Description
It was reported that the bd ultra-fine¿ insulin pen needle jammed during the injection and during priming.The following information was provided by the initial reporter: "consumer reported needle clog during injection, stated that the needle jams when doing injection and sometimes during priming.".
Event or Problem Description
It was reported that the bd ultra-fine¿ insulin pen needle jammed during the injection and during priming.The following information was provided by the initial reporter: "consumer reported needle clog during injection, stated that the needle jams when doing injection and sometimes during priming.".
Additional Manufacturer Narrative
H.6.Investigation summary: no samples and photo were returned for investigation.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 the what customer had experienced as no samples and no photos 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.

• Brand Name: BD ULTRA-FINE¿ INSULIN PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8523975
• Report Number: 8041187-2019-00312
• Device Sequence Number: 2759205
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/17/2019

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: 01/31/2023
• Device Catalogue Number: 320882
• Device Lot Number: 8058370
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 04/02/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 04/30/2019; 05/17/2019
• 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