MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515107

Device Problems Deflation Problem (1149); Fluid/Blood Leak (1250); Occlusion Within Device (1423)

Patient Problem Chemical Exposure (2570)

Event Date 05/29/2018

Event Type  malfunction  

Manufacturer Narrative

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 by the health care worker that the bd phaseal¿ protectors p53 connected the product and drew up chemo medication from the vial.The first time drawing up medication was fine, but the second time the bladder didn't deflate and s/he felt air mixed in the syringe.The healthcare worker then noticed the drug leaked on his/her gloved hand.Found during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: one sample was received for evaluation by our quality engineer team.The sample was evaluated by jfr lab.According to its report: visual inspection shows no defects.The expansion chamber worked properly.No leak found in the expansion chamber.A device history record review did not reveal any anomalies during the production of the provided lot number that could have contributed to the reported defects of leakage and faulty expansion chamber.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 (0,5 bar).It is verified 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.Investigation conclusion: the defect cannot be confirmed upon the evaluation of the sample by jfr lab.No non-conformances were found in dhr.To take into account: in case of the protector is used more than once, liquid of the vial can be accumulated over the filter oversaturating it.An overpressure is created around the hydrophobic filter and no air can be released to the expansion chamber.This can produces significant resistance to inject the air into the vial.On the other hand, in case of liquid was accumulated in the internal face of the vial rubber stopper, it can pass through the protector cannula and be accumulated over filter causing the same effect (resistance to inject the air and leaks into the expansion chamber in case of overpressure).

• Brand Name: BD PHASEAL¿ PROTECTORS P53
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 7611847
• MDR Text Key: 111849458
• Report Number: 3003152976-2018-00236
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 00382905151071
• UDI-Public: 00382905151071
• Combination Product (y/n): N
• PMA/PMN Number: K123213
• 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: 06/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other Health Care Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 515107
• Device Lot Number: 1503021
• Date Manufacturer Received: 05/29/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other