MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P53J; CLOSED DRUG DELIVERY SYSTEM

Catalog Number 515112

Device Problem Leak/Splash (1354)

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

Event Date 10/27/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: leak between protector and vial.Customer complaints about leak between protector and vial.The customer refers that there is ¿an opening¿.No more details about that information has been provided.No pictures/sample are available.The retained samples cannot be checked as the lot is unknown.One p53j of another batch has been tested and no defects have been found.No leak confirmed.Inspections and tests in manufacturing area for protectors: protector housing were manufactured by (b)(4) supplier.Currently, they are molded in bd (b)(4) plant.Visual inspections and critical dimensions for protector housing parts are performed in according to ph-300 current version.Snap fit diameter is measured with a go/no go caliber every 8 hours and after a machine stop.Highness of the protector is measured with a go/no go gauge as well after every machine stop.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 centred in the protector housing, correctly sealed and free of holes or damages.Visual inspection of the filter is performed to verify that is centred 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 (0,5 bar).It is verify if the break is produced in the sealing area of the film or between the protector and the film.Hydrophobic filter leakage is performed to verify that no leaks are present in the filter.Functionality of the protector is also verified.Conclusion: no samples/ pictures/lot have been provided.Without that information, a root cause cannot be established.

Event Description

It was reported that when using the bd phaseal¿ protector p53j, the drug leaked from the opening.There was no report of injury or medical intervention.

• Brand Name: BD PHASEAL¿ PROTECTOR P53J
• Type of Device: CLOSED DRUG DELIVERY SYSTEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7063580
• MDR Text Key: 93827381
• Report Number: 3003152976-2017-00118
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 515112
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/27/2017
• Initial Date FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other