MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P14; INTRAVASCULAR ADMINISTRATION SET

Model Number 515100

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/18/2022

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported while using bd phaseal¿ protector p14 the vial spike punctured the side of the vial top.There was no report of patient impact.The following information was provided by the initial reporter: material no: 515100 batch no: 2105104   verbatim:   this site has had problems with the reconstitution of smaller vials with the bd p14 protector (515100).The vial spike is going through the side of the vial top.

Event Description

It was reported while using bd phaseal¿ protector p14 the vial spike punctured the side of the vial top.There was no report of patient impact.The following information was provided by the initial reporter: material no: 515100, batch no: 2105104.  verbatim:   this site has had problems with the reconstitution of smaller vials with the bd p14 protector (515100).The vial spike is going through the side of the vial top.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 27-apr-2022.H6: investigation summary: multiple photos along with the both the used sample and an unused protector sample were provided to our quality team for investigation.After reviewing the photos, the protector cannula is observed to have penetrated to vial cap.Through visual inspection of the used sample, no damage was observed in the cannula or area where it assembles on the protector housing to indicate improper assembly.A device history review was performed for reported lot 2105104, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.The unused sample along with five retained samples of the same lot were used for additional investigation.All product was visually inspected, no damage or defects were observed.Functional testing was performed, connecting the protector to a vial using the m12 assembly fixture as well as to a sample injector and syringe.In all cases the protector was properly fitted to the vial, the liquid could be withdrawn from the vial, and the product performed as intended.Product undergoes visual and functional testing throughout manufacturing, according to procedure to ensure the quality and functionality of the device.Results were reviewed for lot 2105104, no issues related to the reported incident were identified.Based on our investigation, we are unable to identify a root cause related to our manufacturing process at this time.The m12 assembly fixture must be used in a slow and consistent motion when placing the protector on the vial.

• Brand Name: BD PHASEAL¿ PROTECTOR P14
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13655459
• MDR Text Key: 286645801
• Report Number: 3003152976-2022-00086
• Device Sequence Number: 1
• Product Code: ONB
• UDI-Device Identifier: 30382905151003
• UDI-Public: 30382905151003
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K123213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 515100
• Device Catalogue Number: 515100
• Device Lot Number: 2105104
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1