MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEN NDL 31G 8MM 90 COUNT MAIL ORDER ONLY; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	320881
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/03/2020
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 and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that pen ndl 31g 8mm 90 count mail order only had no insulin flow.This occurred on 10 occasions.The following information was provided by the initial reporter: material no:320881, batch no: 9114901.It was reported that the insulin does not flow and the patient end will not attach to the insulin pen.
Additional Manufacturer Narrative
H6: 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.H3 other text : see h.10.
Event or Problem Description
It was reported that pen ndl 31g 8mm 90 count mail order only had no insulin flow.This occurred on 10 occasions.The following information was provided by the initial reporter: material no:320881 batch no: 9114901.It was reported that the insulin does not flow and the patient end will not attach to the insulin pen.

• Brand Name: PEN NDL 31G 8MM 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: 10906802
• Report Number: 8041187-2020-00779
• Device Sequence Number: 10990485
• Product Code: FMI
• UDI-Device Identifier: 00382903208814
• UDI-Public: 00382903208814
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 12/04/2020

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: 320881
• Device Catalogue Number: 320881
• Device Lot Number: 9114901
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/03/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 11/25/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1