MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE ULTRA¿ PEN NEEDLE

Catalog Number	320141
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 bd micro-fine ultra¿ pen needle the needles were clogged.
Event or Problem Description
It was reported that during use of the bd micro-fine ultra¿ pen needle the needles were clogged.This occurred on 5 separate occasions but the date/time and or patient information is unknown.
Additional Manufacturer Narrative
Describe event or problem: it was reported that during use of the bd micro-fine ultra¿ pen needle the needles were clogged.This occurred on 5 separate occasions but the date/time and or patient information is unknown.Investigation summary: 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.

• Brand Name: BD MICRO-FINE ULTRA¿ PEN NEEDLE
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8206996
• Report Number: 9616656-2018-00350
• Device Sequence Number: 19249949
• Product Code: FMI
• UDI-Device Identifier: 30382903814672
• UDI-Public: 30382903814672
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K131358
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,foreign,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2019

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: 02/28/2022
• Device Catalogue Number: 320141
• Device Lot Number: 7052834
• Initial Date Received by Manufacturer: 12/12/2018
• Supplement Date Received by Manufacturer: 12/12/2018
• Initial Report FDA Received Date: 12/31/2018
• Supplement Report FDA Received Date: 01/24/2019
• 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