MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD¿ PROTECTOR P13-O

Catalog Number 515060

Device Problem Mechanical Problem (1384)

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

Event Date 03/11/2019

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 when preparing pralatrexate, the blue adaptor of a bd¿ protector p13-o was added to vial, and it pushed the rubber stopper right through into the vial.Customer¿s verbatim: ¿ when preparing pralatrexate, added blue adaptor to vial and it pushed the rubber stopper right through into the vial.Unable to use drug, which is supplied compassionately.Still had enough drug to give patient¿s dose today.¿.

Manufacturer Narrative

Investigation: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for the provided lot number 1805505, no deviations or non-conformances were identified during the manufacturing process related to this incident.Four retained samples were used for further evaluation.Visual inspection did not reveal any defects, samples were attached to the vial without issue.There was no displacement of the rubber stopper and liquid could be drawn from the vials succesfully.Based on the available information, we are not able to determine a root cause at this time.

Event Description

It was reported that when preparing pralatrexate, the blue adaptor of a bd¿ protector p13-o was added to vial, and it pushed the rubber stopper right through into the vial.Customer¿s verbatim: ¿ when preparing pralatrexate, added blue adaptor to vial and it pushed the rubber stopper right through into the vial.Unable to use drug, which is supplied compassionately.Still had enough drug to give patient¿s dose today.¿.

• Brand Name: BD¿ PROTECTOR P13-O
• Type of Device: PROTECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8466236
• MDR Text Key: 140946200
• Report Number: 3003152976-2019-00225
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• 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: 04/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 515060
• Device Lot Number: 1805505
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other