MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM HP 100 BOX FR; PEN NEEDLE

Catalog Number	320562
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone#: (b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the pen ndl 32g 4mm hp 100 box fr the needle was clogged and the injection could not be made.Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: needle clog.Injection could not be made.
Additional Manufacturer Narrative
Investigation: no samples or photos were returned for analysis.A lot history review was carried out and no related non conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Root cause could not be determined and complaint is unconfirmed.
Event or Problem Description
It was reported that during use of the pen ndl 32g 4mm hp 100 box fr the needle was clogged and the injection could not be made.Foreign complaint the following information was provided by the initial reporter, translated from french to english: needle clog.Injection could not be made.

• Brand Name: PEN NDL 32G 4MM HP 100 BOX FR
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8675536
• Report Number: 9616656-2019-00515
• Device Sequence Number: 1857889
• Product Code: FMI
• UDI-Device Identifier: 00382904736989
• UDI-Public: 00382904736989
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 07/08/2019

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: 08/31/2023
• Device Catalogue Number: 320562
• Device Lot Number: 8205958
• Initial Date Received by Manufacturer: 05/17/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 07/08/2019
• 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