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

Catalog Number	515060
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem 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.¿.
Additional 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 or Problem 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
• Common Device Name: PROTECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 8466236
• Report Number: 3003152976-2019-00225
• Device Sequence Number: 1576595
• Product Code: LHI
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2019

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
• Operator of Device: Other
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 515060
• Device Lot Number: 1805505
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/29/2019
• Supplement Report FDA Received Date: 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other