MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; PHASEAL ADMINISTRATION SET

Catalog Number 515111

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/31/2018

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 that the expansion chamber on the bd phaseal¿ protector p50j was "unable to shrink".There was no report of exposure, injury, or medical intervention.

Manufacturer Narrative

As a lot number is unknown for this incident, a complaint history check could not be completed.Quantity of customer samples: according to jfrl report: the protector fitted properly the vial.The expansion chamber could expand but couldn¿t be shrined.It was difficult to see the needle though the rubber stopper.Expansion chamber does not work.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 of the film or between the protector and 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.According to jfrl report, the expansion chamber worked without any issues after having reconnected the protector using m12.This fact suggests that the protector was not properly attached to the vial and therefore it didn¿t work properly.Note that is difficult to see the needle of the protector as the rubber stopper is too thick.If the thickness of the rubber stopper is not the appropriate, there can be issues related to the normal function of protectors.In this case, this potential impediment was avoided using m12.The fixture makes easier the connection.

Event Description

It was reported that the expansion chamber on the bd phaseal protector p50j was "unable to shrink".There was no report of exposure, injury, or medical intervention.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Type of Device: PHASEAL ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7901368
• MDR Text Key: 121588795
• Report Number: 3003152976-2018-00411
• 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: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• 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: 09/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other