MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515107

Device Problem Unintended Ejection (1234)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd phaseal¿ protectors p53 leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

One sample unit was received for evaluation by our quality engineer team.Upon visual inspection of the sample, leakage was not observed.The protector was found to properly fit the vial and no visual defects were found in regards to the product components.A device history record review did not reveal any issues during the production of lot number 1503021 that could have contributed to the reported defect.No qn¿s or other issues were found during dhr review.The leak was not confirmed on sample involved in the complaint.No evidences of failure during manufacturing process were found.No root cause found.

Event Description

It was reported that bd phaseal protectors p53 leaked.No serious injury or medical intervention was reported.

• Brand Name: BD PHASEAL¿ PROTECTORS P53
• 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: 7842453
• MDR Text Key: 119501400
• Report Number: 3003152976-2018-00389
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905151071
• UDI-Public: 00382905151071
• 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: 10/02/2018

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 Expiration Date: 02/29/2020
• Device Catalogue Number: 515107
• Device Lot Number: 1503021
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/04/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 10/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other