MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 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	09/26/2019
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 5 pen ndl 31g 5mm experienced inability or difficult to prime during use.The following information was provided by the initial reporter: material no.320882.Batch no.8231386.Issue(s): needle clogged during flow check with insulin.Found 5 pen needles date of event: unknown.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.
Event or Problem Description
It was reported that 5 pen ndl 31g 5mm experienced inability or difficult to prime during use.The following information was provided by the initial reporter: material no.320882, batch no.8231386.Issue(s): needle clogged during flow check with insulin.Found 5 pen needles date of event: unknown.

• Brand Name: 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: 9180457
• Report Number: 8041187-2019-00810
• Device Sequence Number: 438989
• Product Code: FMI
• UDI-Device Identifier: 10885403897504
• UDI-Public: 10885403897504
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/22/2019

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 320882
• Device Lot Number: 8231386
• Initial Date Received by Manufacturer: 09/26/2019
• Supplement Date Received by Manufacturer: 09/26/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 10/22/2019
• 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