MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; CLOSED SYSTEM DRUG DELIVERY

Catalog Number 515111

Device Problem Inflation Problem (1310)

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

Event Date 09/07/2018

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¿ protector p50j exhibited bladder inflation failure.No serious injury or medical intervention was reported.

Manufacturer Narrative

Lot number 1802114 for product (b)(4) was provided for evaluation by our quality engineer.A device history record review did not reveal any documented quality issues during the production of lot number 1802114 that could have contributed to the reported incident.As a sample was not provided, a thorough sample investigation could not be competed.Two retained samples of the same lot number were obtained for further investigation.Through visual inspection of the retained samples, no defects were observed.The retained samples were functionally tested and the expansion chambers were observed to expand properly.If the protector product is used more than once, liquid may accumulate and oversaturate the hydrophobic filter.If oversaturation occurs, the resulting pressure can prevent proper release of air to the expansion chamber.The same pressure prevention may occur if liquid accumulates within the internal face of the vial rubber stopper.Based on the investigation results, a definite cause for the reported incident could not be determined.Complaints received for the reported defect and device will continue to be monitored for emerging trends.This is the first complaint of expansion chamber does not work for lot 1802114, product (b)(4).No actions indicated as the defect was not confirmed.

Event Description

It was reported that bd phaseal protector p50j exhibited bladder inflation failure.No serious injury or medical intervention was reported.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: CLOSED SYSTEM DRUG DELIVERY
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7926097
• MDR Text Key: 122631055
• Report Number: 3003152976-2018-00415
• Device Sequence Number: 1
• Product Code: LHI
• 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: 11/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 515111
• Device Lot Number: 1802114
• Date Manufacturer Received: 09/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other