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

Catalog Number	515111
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported during use of the bd phaseal" protector p50j when preparing vincristine sulfate (chemo), it leaked from the connection of the vial and the protector.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Results: according to (b)(6) report, no leak was confirmed.On the returned sample, the needle was found bent at the root and the protector was not centered in the vial.It seems that the product was not properly handled.This could cause the leak that the customer complaints about.To guarantee the proper function of phaseal products, instructions explained in the ifu must be followed.Protectors must be connected vertically to the vials.M12 assembly fixture makes the connection easier.During the manufacturing process several tests and inspections are carried out to avoid faulty parts, including the following.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.Phaseal needles are designed to reduce the coring tendency.For every manufactured lot the laboratory technician made the particles fragmentation test.As the lot number is unknown, device history record and retained samples cannot be checked.Conclusion: based on the low severity and frequency of the defect, it was determined that no capa is required.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD PHASEAL¿ PROTECTOR P50J
• Common Device Name: PHASEAL INJECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7133908
• Report Number: 3003152976-2017-00204
• Device Sequence Number: 117259
• Product Code: ONG
• Combination Product (Y/N): N
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

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
• Operator of Device: Other
• Device Catalogue Number: 515111
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2017
• Initial Date Received by Manufacturer: 08/21/2017
• Supplement Date Received by Manufacturer: 08/21/2017
• Initial Report FDA Received Date: 12/20/2017
• Supplement Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other