MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515111

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2021

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.

Event Description

It was reported when using the bd phaseal¿ protector p50j there was a damaged or open unit package seal where sterility is compromised.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the perforation of package was poor (torn).".

Manufacturer Narrative

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 when using the bd phaseal¿ protector p50j there was a damaged or open unit package seal where sterility is compromised.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the perforation of package was poor (torn).".

Event Description

It was reported when using the bd phaseal¿ protector p50j there was a damaged or open unit package seal where sterility is compromised.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "the perforation of package was poor (torn).".

Manufacturer Narrative

Investigation summary: no samples or pictures were received for the investigation.A device history review was performed for reported lot 2105131, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Five retained samples from the same lot were investigated, no damage or problems related to package seal integrity were found.All packages were properly sealed and therefore the reported event could not be reproduced in the retained samples.No damage or problems related to the integrity of the container seal were found.All containers were properly sealed and no defects were observed.The protectors are automatically placed in the blister pockets and the packages are checked at the beginning and end of the pallet.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.H3 other text : see h10.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13002535
• MDR Text Key: 285474823
• Report Number: 3003152976-2021-00815
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: 2105131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1