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 Information (3190)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(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 a large quantity of the needles were defective "clogged".Foreign complaint the following information was provided by the initial reporter, translated from (b)(6) to english: complaint about a box of 100 bd needles 4mm (3401321104311) ref: 320562, lot: 8186912, exp: 31/07/2023.A patient made us a report by bringing back the empty box, stating that a large quantity of needles were defective.Update due to mail received on may 14: needle clog.
Event or Problem Description
It was reported that during use of the pen ndl 32g 4mm hp 100 box fr a large quantity of the needles were defective "clogged." foreign complaint the following information was provided by the initial reporter, translated from french to english: complaint about a box of 100 bd needles 4mm ((b)(4).) ref: 320562 lot: 8186912 exp: 31 07 2023.A patient made us a report by bringing back the empty box, stating that a large quantity of needles were defective.Update due to mail received on may 14: needle clog.
Additional Manufacturer Narrative
Investigation summary: no samples or photos were returned for analysis.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.

• 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: 8662826
• Report Number: 9616656-2019-00499
• Device Sequence Number: 11335953
• Product Code: FMF
• 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): 06/28/2019

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: 07/31/2023
• Device Catalogue Number: 320562
• Device Lot Number: 8186912
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 06/03/2019
• Supplement Report FDA Received Date: 06/28/2019
• 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