MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515105

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Information (3190)

Event Date 11/07/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 during use of the bd phaseal¿ protector p50 there was an issue with flow.

Manufacturer Narrative

Investigation summary: no non-conformance's or other events were found during dhr review.2 unopened samples were received for investigation.Expansion chamber does not work.Visual inspection shows no defects.They were connected to a vial and functional test was performed: expansion chamber worked properly and no flow issues were found.The liquid can move through the set (protector + injector + syringe) without issues.Inspections and tests in manufacturing area for protectors: protector housing were manufactured by nolato supplier.Currently, they are molded in bd san agustin plant.Visual inspections and critical dimensions for protector housing parts are performed according to ph-300 current version.During assembly process, the operator performs the following inspections and tests according to ph-302 current version: it is verified that expansion film of the bladder is centered in the protector housing, correctly sealed and free of holes or damages.Visual inspection of the filter is performed to verify that is centered in the protector cavity, welded in a right position and free of holes between the filter and filter cover.Overpressure test is performed to verify that the expansion film of the bladder can resist certain pressure.Film breakage test: the expansion film of the bladder must break at minimum pressure (0,8 bar).It is verify if the break is produced in the sealing area or at the film.Functionality test is performed to ensure properly work of the protector.Hydrophobic filter leakage is performed to verify that no leaks are present in the filter.The defect cannot be confirmed.To take into account: in case of 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.-on the other hand, in case of 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).Taking into account the description of the complaint (there was resistance and the plunger of the syringe move back.The balloon of protector did not fill with air) it seems possible that the filter was oversaturated.To avoid this, it is important to carefully follow the instructions explained in the ifu (dgp102).The defect was not confirmed on samples received.The defect described by the customer seems to be caused by a misuse of the device.

Event Description

It was reported that during use of the bd phaseal¿ protector p50 there was an issue with flow.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8124198
• MDR Text Key: 129469227
• Report Number: 3003152976-2018-00519
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: 30382905151058
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• 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: 01/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 515105
• Device Lot Number: 1506009
• Date Manufacturer Received: 11/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other