MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P50 MULTIPACK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515106

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

Patient Problem No Patient Involvement (2645)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the protector p50 multipack experienced foreign matter/ coring.The following information was provided by the initial reporter: during preparation, the hcp found an fm on the product.

Manufacturer Narrative

H.6.Investigation: one protector sample was returned to our quality team for investigation.Through visual inspection, a blue material was observed between the protector housing and film from the protector.Using magnification, the material was identified to be from the materials used to cover shoes for individuals that enter the clean room.A device history review was performed for the reported lot 2003135, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.While we could not identify a direct issue, the root cause of this incident is due to personnel.

Event Description

It was reported that the protector p50 multipack experienced foreign matter/coring.The following information was provided by the initial reporter: during preparation, the hcp found an fm on the product.

• Brand Name: PROTECTOR P50 MULTIPACK
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10939379
• MDR Text Key: 219368601
• Report Number: 3003152976-2020-00544
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905151064
• UDI-Public: 00382905151064
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• 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: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515106
• Device Lot Number: 2003135
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1