MAUDE Adverse Event Report: BECTON DICKINSON HOLDER ONE USE JPN

Catalog Number 368839

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Injury (2348)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: n/a.The manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 molding protrusions were found with a holder one use jpn.The following information was provided by the initial reporter, "customer got injured by the burr on the holder.The issue occurred twice." 2 occurrences were reported.

Manufacturer Narrative

H.6.Investigation: bd received samples from the customer facility for investigation.The samples were evaluated and the customer¿s indicated failure mode for burrs on the holders with the incident lot was observed.Dhr could not be performed as the reported batch# was not found for the catalog#.

Event Description

It was reported that molding protrusions were found with a holder one use jpn.The following information was provided by the initial reporter, "customer got injured by the burr on the holder.The issue occurred twice." 2 occurrences were reported.

• Brand Name: HOLDER ONE USE JPN
• Type of Device: HOLDER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9525462
• MDR Text Key: 177846679
• Report Number: 2243072-2019-02901
• Device Sequence Number: 1
• Product Code: JKA
• 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,other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 368839
• Device Lot Number: 1905BD03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other