MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50J; CLOSED SYSTEM DRUG DELIVERY

Catalog Number 515111

Device Problems Leak/Splash (1354); Misconnection (1399)

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

Event Date 09/14/2018

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 bd phaseal¿ protector p50j exhibited connection failure and leaked.No serious injury or medical intervention was reported.

Event Description

It was reported that bd phaseal¿ protector p50j exhibited connection failure and leaked.No serious injury or medical intervention was reported.

Manufacturer Narrative

Investigation summary: dhr: n/a - no lot available quantity of customer samples: 2 (injector +protector).Conclusion(s): 1 protector + 1 injector were tested by jfrl.According to the report the defect was not confirmed.According to the report: visual inspection shows no defects in both injector and connector samples.N35 could connect to protector properly.Function test is acceptable (expansion chamber inflates properly and it is possible to draw drug).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.To perform the two last test the protector needs to be connected to an injector.Investigation conclusion: according to jfrl report, the claimed defect was not confirmed.The root cause cannot be established.

• 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: 7958072
• MDR Text Key: 123520618
• Report Number: 3003152976-2018-00430
• 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
• Report Date: 11/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2018
• 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
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other