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

Catalog Number 515112

Device Problem Fluid/Blood Leak (1250)

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

Event Date 11/02/2017

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.Device manufacture date: unknown.Investigation: leak between the protector and the vial.According (b)(6) report, no leak confirmed.However, the protector was connected inclined to the vial.Inspections and tests in manufacturing area for protectors: protector housing were manufactured by nolato 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.Among them, snap fit diameter is measured with a go/no go caliber.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 (0,5 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.Conclusion: according jfrl report, no leak confirmed.However, the protector was connected inclined to the vial.If the protector is not vertically assembled, it might work badly and leak could occur.To avoid this, instructions explained in the ifu must be carefully followed.M12 assembly fixture makes easier the connection.As the lot is unknown, dhr cannot be checked.

Event Description

It was reported that a bd phaseal¿ protector p53j leaked between the protector and vial during use.No 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: 7060603
• MDR Text Key: 93615903
• Report Number: 3003152976-2017-00131
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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