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 Consequences Or Impact To Patient (2199)

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that the bladder of a bd phaseal¿ protector p50j didn¿t inflate. There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: three unused sample units were received for evaluation by our quality engineer team. Upon inspection of the samples, no defects were observed. The expansion chambers of all three units expanded properly. A device history record review did not reveal any deviations or non-conformances during the production of the provided lot number that could have contributed to the reported issue. Based on the investigation results, a cause for the reported defect could not be determined. It is important to note that if the protector is used more than once, the filter may become oversaturated and prevent proper air release to the expansion chamber. The same resistance can occur if liquid accumulates in the internal face of the vial rubber stopper. This is a single use device. If the protector is used more than once, liquid of the vial can be accumulated over the filter oversaturating it. An overpressure is created around the hydrophobic filter and no air can be released to the expansion chamber. This can produces significant resistance to inject the air into the vial. If liquid was accumulated in the internal face of the vial rubber stopper, it can pass through the protector cannula and be accumulated over filter causing the same effect (resistance to inject the air and leaks into the expansion chamber in case of overpressure). It is recommended to carefully follow the instructions explained in the ifu. Conclusion: this complaint is related to another complaint in which retained samples of the involved lot (#1702025) were taken for evaluation and no issues were found. It is not possible to establish the root cause of the defect, as no issues were found in retained and received samples. Based on the low severity and frequency of the defect, it was determined that no capa is required.

Event Description

It was reported that the bladder of a bd phaseal¿ protector p50j didn¿t inflate. There was no report of exposure, injury or 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: 7616090
• MDR Text Key: 111921116
• Report Number: 3003152976-2018-00247
• 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: 08/23/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 515111
• Device Lot Number: 1702025
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/01/2018
• Is This a Reprocessed and Reused Single-Use Device?: No

Patient Treatment Data

Date Received: 06/19/2018 Patient Sequence Number: 1