MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P55; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515117

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

Patient Problem No Information (3190)

Event Date 02/08/2019

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that before use of the bd phaseal¿ protector p55 there was foreign matter in the bladder of the protector.

Manufacturer Narrative

H.6.Investigation: one physical sample and multiple photos were provided to our quality engineer for investigation.Upon visual inspection, a particle was observed on the product which was determined to be an embedded particle originating from the manufacturing process.A device history review was performed for the provided lot number 1808112, no deviations or non-conformances were identified during the manufacturing process that could have contributed to the reported incident.This issue typically occurs within the molding process as a result of a punctual defect.

Event Description

It was reported that before use of the bd phaseal¿ protector p55 there was foreign matter in the bladder of the protector.

• Brand Name: BD PHASEAL¿ PROTECTOR P55
• 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: 8401352
• MDR Text Key: 141599049
• Report Number: 3003152976-2019-00193
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151171
• UDI-Public: 30382905151171
• Combination Product (y/n): N
• PMA/PMN Number: K130197
• 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: 03/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 515117
• Device Lot Number: 1808112
• Date Manufacturer Received: 02/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other