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 07/17/2018

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 with the use of the bd phaseal¿ protector p50j there was an issue with malfunction.It was reported that ¿the bladder didn't inflate from the 2nd try.¿ there was no report of injury or further medical intervention.

Event Description

It was reported with the use of the bd phaseal¿ protector p50j there was an issue with malfunction.It was reported that ¿the bladder didn't inflate from the 2nd try.¿ there was no report of injury or further medical intervention.

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.

Manufacturer Narrative

H.6.Investigation summary: one sample unit was received for evaluation by our quality engineer team.Upon visual inspection of the sample, no defects were observed.Through functionality testing of the sample, it was observed that the expansion chamber worked properly.As a lot number was unavailable for this incident, a production history review could not be completed and additional retained samples could not be evaluated.If the protector is used more than once, liquid can accumulate and oversaturate the filter.The oversaturation can create a pressure around the hydrophobic filter which prevents proper air release to the expansion chamber.The same overpressure may occur if liquid accumulates within the internal face of the vial rubber stopper.It is recommended that the instructions for use are carefully followed when using the protector product.Investigation conclusion: based on the investigation results, a definite cause could not be determined for this incident.

Event Description

It was reported with the use of the bd phaseal¿ protector p50j there was an issue with malfunction.It was reported that ¿the bladder didn't inflate from the 2nd try.¿ there was no report of injury or further medical intervention.

• 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: 7749188
• MDR Text Key: 116270292
• Report Number: 3003152976-2018-00348
• Device Sequence Number: 1
• Product Code: ONB
• 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,Followup
• Report Date: 09/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other