MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P50J; PHA SEAL PROTECTOR

Catalog Number 515111

Device Problem Structural Problem (2506)

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

Event Date 04/01/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that two protector p50j experienced coring.The following information was provided by the customer: after preparing hd(herceptin), fm was found which can be created by coring.

Event Description

It was reported that two protector p50j experienced coring.The following information was provided by the customer: after preparing hd(herceptin), fm was found which can be created by coring.

Manufacturer Narrative

Investigation: one sample was returned for evaluation by our quality team.Upon visually inspecting the product, a hole in the rubber stopper was observed and a grey elastic matter identified which appears to have generated from the rubber stopper.No defects were found on the protector needle.A device history review could not be performed as no lot information was provided.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the available information we are not able to identify a definitive root cause at this time.Prior to the investigation of this complaint, capa#688697, was open to asses coring defect.

• Brand Name: PROTECTOR P50J
• Type of Device: PHA SEAL PROTECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8519289
• MDR Text Key: 145280694
• Report Number: 3003152976-2019-00272
• Device Sequence Number: 1
• Product Code: LHI
• 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: 06/06/2019

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: 515111
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 04/01/2019
• Initial Date FDA Received: 04/16/2019
• Supplement Dates Manufacturer Received: 04/01/2019
• Supplement Dates FDA Received: 06/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other