MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NANO¿ ULTRA-FINE¿ PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	8975
Medical Device Problem Codes	Failure to Deliver (2338); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 1 bd nano¿ ultra-fine¿ pen needle was difficult to operate and there were 9 needles that were unable to deliver medication.The following information was provided by the initial reporter: on (b)(6) 2021, used bd nano ultra-fine pen needles and have had 10 defective needles in this supply lot #0160115 exp: 7-31-2025.
Additional Manufacturer Narrative
Date of event: unknown.Initial reporter state: address information was not able to be obtained, therefore, (b)(6)was used as a place holder.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 2021-12-31.H6: investigation summary: customer returned (10) 32gx4mm bd pen needles without tear drop labels attached.The consumer reported 10 defective needles: 9 pen needles would not release insulin, 1 pen needle had a needle bent over under the green cap after opening.All 10 returned pen needles were examined, and the following was observed: 7 exhibited a bent non-patient end (npe) cannula - 1 exhibited a broken npe cannula none of the returned samples exhibited a bent patient end (pe) cannula.2 samples with straight npe cannulas were tested for flow using a test pen injector, and both were able to expel properly.The bent and broken non-patient end (npe) cannulas would be the cause for any difficulty when using the pen needles, hence, the customer would think the pen needles were defective or clogged.Since the samples were returned after use, the probable cause of the bent and broken npe cannulas is user related.Pen needle dhr batch 0160115 was reviewed: the batch number was built with pen needle assembly line in (b)(6) 2020.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.Bd was able to duplicate or confirm the customer¿s indicated failure (npe cannula bent npe cannula broken) the root cause for this issue is user related.The npe cannulas were bent or broken after the user handled the pen needles.
Event or Problem Description
It was reported that 1 bd nano¿ ultra-fine¿ pen needle was difficult to operate and there were 9 needles that were unable to deliver medication.The following information was provided by the initial reporter: (b)(6) 2021: used bd nano ultra-fine pen needles and have had 10 defective needles in this supply lot #0160115; exp: 7-31-2025.

• Brand Name: BD NANO¿ ULTRA-FINE¿ PEN NEEDLE
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12929630
• Report Number: 8041187-2021-01020
• Device Sequence Number: 3900116
• Product Code: FMI
• UDI-Device Identifier: 10885403897511
• UDI-Public: 10885403897511
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K131358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2022

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: 07/31/2025
• Device Model Number: 8975
• Device Catalogue Number: 320883
• Device Lot Number: 0160115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/31/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2021
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 01/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown