MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD MICROLANCE¿ NEEDLES

Catalog Number 304622

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 12/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.(b)(6).Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd microlance¿ needle had a hair on a new hypodermic needle.

Manufacturer Narrative

Investigation summary: since no sample neither picture has been provided, we were unable confirm your indicated failure mode, so no root cause was possible to determine at this time.No dhr was performed as the lot number is unknown.

Event Description

It was reported that bd microlance¿ needle had a hair on a new hypodermic needle.

Manufacturer Narrative

Correction: in section h.10 of the previously submitted mdr, sections d.1 and h.1 were incorrectly referenced as the medical device expiration date and device manufacture date.This supplemental mdr is being submitted to correct those references to show the following: medical device expiration date and device manufacture date.

Event Description

It was reported that bd microlance¿ needle had a hair on a new hypodermic needle.

• Brand Name: BD MICROLANCE¿ NEEDLES
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga
• MDR Report Key: 8204449
• MDR Text Key: 131775284
• Report Number: 3002682307-2018-00336
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

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
• Device Operator: Other
• Device Catalogue Number: 304622
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 12/11/2018
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: 12/11/2018; 12/11/2018
• Supplement Dates FDA Received: 01/17/2019; 01/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other