MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTORS P53; INTRAVASCULAR ADMINISTRATION SET

Model Number	515107
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/12/2020
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.(b)(4).
Event or Problem Description
It was reported that 4 bd phaseal¿ protectors p53 experienced leakage between the protector and vial during use.The following information was provided by the initial reporter: leakage between vial and protector (p53) when preparing piperacillin/tazobactam.This has happened at least 4 times.All from the same lot no.Normally they are using p21 for smaller drug vials with diameter 20 mm, from fresenius kabi.Now this size is on backorder they have instead received larger vials with diameter 32 mm and therefore need the p53 protector to fit.These vials are from (b)(6), with (b)(6) labeled vials.
Event or Problem Description
It was reported that 4 bd phaseal¿ protectors p53 experienced leakage between the protector and vial during use.The following information was provided by the initial reporter: leakage between vial and protector (p53) when preparing piperacillin/tazobactam.This has happened at least 4 times.All from the same lot no.Normally they are using p21 for smaller drug vials with diameter 20mm, from fresenius kabi.Now this size is on backorder they have instead received larger vials with diameter 32 mm and therefore need the p53 protector to fit.These vials are from germany, with german labeled vials.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for evaluation?: yes.D.10.Returned to manufacturer on: (b)(6) 2020.H.6.Investigation: one protector sample connected to a vial from piperacillin/tazobactam fresenius kabi, along with two unused protectors and two unused vials of piperacillin/tazobactam fresenius kabi vials were provided to our quality team for investigation.The protectors were visually inspected, no damage or defects were observed on the protectors or protector needles.Functional testing was performed on all samples, connecting the unused samples to the vials of piperacillin/tazobactam using the m12 fixture.In all cases liquid inside the syringe could move to the vial and back to the syringe without issue, the expansion chamber expanded properly, the product functioned as intended, and no leakages were observed.A device history review was performed for reported lot 1910114, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this reported issue.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.Testing results were reviewed for lot 1910114 and no issues related to the reported incident were identified.Based on the available information we are not able to determine a root cause at this time.

• Brand Name: BD PHASEAL PROTECTORS P53
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10365718
• Report Number: 3003152976-2020-00342
• Device Sequence Number: 2942879
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123213
• 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): 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2024
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: 1910114
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/14/2020
• Supplement Date Received by Manufacturer: 07/14/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 09/29/2020
• 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