MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14J; CLOSED DRUG DELIVERY SYSTEM

Catalog Number 515109

Device Problems Bent (1059); Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported when preparing eribulin (chemo) medication using the bd phaseal¿ protector p14j, the hcp connected to the vial by his/her hands without assembly fixture.When drawing up medication drug, a leak occurred.It seems the needle was bent and disconnected the protector.Found during use.No reports of serious injury or medical intervention reported.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation by our quality engineer team.Upon examination of the sample protector, the needle was observed detached, therefore, a functionality test could not be performed to confirm the reported defect of leakage.Phaseal protectors are intended for single use.After the preparation of the drug, the protector must be disposed of with the vial, as explained in the instructions for use.Once the protector is attached, it cannot be properly removed.The rubber stopper of the vial showed three puncture holes.Taking into account the detachment of the needle and the punctures within the rubber stopper, it seems likely that the protector was not correctly attached on the first attempt.If the protector was removed and reattached, that could result in the reported leakage and the observed needle detachment.As a lot number was not available for this incident, a production history review could not be performed and retained samples could not be obtained from the manufacturing facility.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 the protector works properly.- hydrophobic filter leakage is performed to verify that no leaks are present in the filter.Based on the information provided by jfrl report, it seems likely that the problem was caused by a bad handling of the protector.In this case, as the lot is unknown, retained samples and the dhr cannot be evaluated.Based on the low severity and frequency of the defect, it was determined that no capa is required.

• Brand Name: BD PHASEAL¿ PROTECTOR P14J
• Type of Device: CLOSED DRUG DELIVERY SYSTEM
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7492599
• MDR Text Key: 107917530
• Report Number: 3003152976-2018-00162
• 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: 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515109
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 04/13/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other