MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P50 MULTIPACK; INTRAVASCULAR ADMINISTRATION SET

Model Number 515106

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/08/2020

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 that the protector p50 multipack experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: during inspection after preparation of abraxane, coring was found in infusion bags and 2 of 3 vials.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 7/16/2020.H.6.Investigation: two protectors attached to two vials were provided to our quality team for investigation.The product was visually inspected, no defects or damage observed on the protectors, the needle on the protector penetrated the vial stopper properly, however it was noted the plastic cover from the vial was not removed before connecting the protector to the vial.During our evaluation, a foreign particle was observed inside the vial.After further evaluation we found the particle was consistent with material from the rubber stopper of the vial.A device history review was performed for reported lot 2001112, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this incident.Fragmentation testing is performed according to procedure, to evaluate any particulates generated after ten activations.Fragmentation testing was reviewed for the reported lot and results were found to be acceptable.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 we are not able to identify a definitive root cause at this time.H3 other text : see h.10.

Event Description

It was reported that the protector p50 multipack experienced foreign matter contamination which was noted prior to use.The following information was provided by the initial reporter: during inspection after preparation of abraxane, coring was found in infusion bags and 2 of 3 vials.

• Brand Name: PROTECTOR P50 MULTIPACK
• 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: 10348370
• MDR Text Key: 202751401
• Report Number: 3003152976-2020-00332
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 50382905151069
• UDI-Public: 50382905151069
• 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: 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515106
• Device Catalogue Number: 515106
• Device Lot Number: 2001112
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 07/08/2020
• Initial Date FDA Received: 07/30/2020
• Supplement Dates Manufacturer Received: 07/08/2020
• Supplement Dates FDA Received: 09/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other