MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P14J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515109

Device Problem Leak/Splash (1354)

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

Event Date 12/11/2019

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 leakage occurred between the bd phaseal¿ protector p14j and vial during use while drawing up "3cc of keytruda".The following information was provided by the initial reporter, translated from (b)(6) to english: "when drawing about 3cc of keytruda, hcp confirmed leakage on the glove.It may leaked from between the protector and the vial.".

Event Description

It was reported that leakage occurred between the bd phaseal¿ protector p14j and vial during use while drawing up "3cc of keytruda".The following information was provided by the initial reporter, translated from japanese to english: "when drawing about 3cc of keytruda, hcp confrmed leakage on the glove.It may leaked from between the protector and the vial.".

Manufacturer Narrative

H.6.Investigation: one sample was returned to our quality team for investigation.The product was evaluated and no damage or defects were observed.Functional testing was performed on the sample, no leak between the protector and vial was identified.While the protector was properly fitted to the vial, it was noted that the needle on the protector was detached from the protector housing.A device history review was performed for lot 1904117, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.Based on the investigation results, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: BD PHASEAL PROTECTOR P14J
• 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: 9526011
• MDR Text Key: 190672090
• Report Number: 3003152976-2019-00883
• Device Sequence Number: 1
• Product Code: FPA
• 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: 03/31/2020

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: Health Professional
• Device Expiration Date: 03/31/2024
• Device Catalogue Number: 515109
• Device Lot Number: 1904117
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/11/2019
• Initial Date FDA Received: 12/27/2019
• Supplement Dates Manufacturer Received: 12/11/2019
• Supplement Dates FDA Received: 04/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other