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 07/30/2018

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 the bladder did not inflate on a bd phaseal¿ protector p50j.No serious injury or medical intervention was reported.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other; device single use?: no; device returned to manufacture: yes.Investigation summary: two sample units were returned for evaluation by our quality engineer team.Upon visual inspection of the samples, defects could not be observed.Upon functionality testing of the samples, the expansion chambers were found to properly function.As a lot number was unknown for this incident, a production history review could not be completed.Regular inspections and tests are performed during the manufacturing process to ensure product is within specifications.If the protector is used more than once, liquid may accumulate within the filter causing an oversaturation of the hydrophobic filter.If oversaturation occurs, pressure prevents proper air release to the expansion chamber.The same pressure may result if liquid accumulates within the internal face of the vial rubber stopper.

Event Description

It was reported that the bladder did not inflate on a bd phaseal¿ protector p50j.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: 7794477
• MDR Text Key: 117724491
• Report Number: 3003152976-2018-00359
• 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: 09/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 08/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other