MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTOR P15J; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 515121

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.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.(b)(4).

Event Description

It was reported that chemo leaked from 2 bd phaseal¿ protector p15j devices during use.The following information was provided by the initial reporter, translated from (b)(6) to english: "the hcp attached protector 515121 to a vial of 5fu and aspirated into a syringe; during this operation, chemo leaked.This issue occurred in 2 cases.".

Event Description

It was reported that chemo leaked from 2 bd phaseal¿ protector p15j devices during use.The following information was provided by the initial reporter, translated from japanese to english: "the hcp attached protector 515121 to a vial of 5fu and aspirated into a syringe; during this operation, chemo leaked.This issue occurred in 2 cases.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 1/26/2021.H.6.Investigation: two protectors were returned to our quality team for investigation.The product was visually inspected, no damage or defects were observed on the protector or protector membrane ad the needle properly penetrated the vial stopper, one sample was noted to have penetrated the stopper slightly off center.Functional testing was completed, liquid inside the syringe could move to the vial and back to the syringe without issue and no leaks were observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.As the lot involved in this incident is unknown, a device history review could not be performed and additional retained samples could not be evaluated.Based on our investigation, we cannot identify a root cause related to our manufacturing process at this time.H3 other text : see h.10.

• Brand Name: BD PHASEAL PROTECTOR P15J
• 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: 11103396
• MDR Text Key: 227977291
• Report Number: 3003152976-2020-00594
• Device Sequence Number: 1
• Product Code: ONB
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 515121
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2021
• Date Manufacturer Received: 03/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1