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

Catalog Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
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 the bd phaseal¿ protector p53 could not be secured properly "when used for piperacillin / tazobactam", and leaked during use between the vial and protector when "tilted".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "leakage when used for piperacillin / tazobactam".When customers use the drug piperacillin / tazobactam from the drug company, it is not possible to attach the protector so it becomes tight.Since the vial is manufactured in a way that the protector cannot be secured properly.This complaint is that it leaks fluid between the vial and the protector when you tilt the vial.The customer cannot see if the drug is between injector and prosthetor as well.
Event or Problem Description
It was reported that the bd phaseal¿ protector p53 could not be secured properly "when used for piperacillin / tazobactam", and leaked during use between the vial and protector when "tilted".This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter: "leakage when used for piperacillin / tazobactam".When customers use the drug piperacillin / tazobactam from the drug company, it is not possible to attach the protector so it becomes tight.Since the vial is manufactured in a way that the protector cannot be secured properly.This complaint is that it leaks fluid between the vial and the protector when you tilt the vial.The customer cannot see if the drug is between injector and prosthetor as well.
Additional Manufacturer Narrative
H.6.Investigation summary: twenty six samples along with one photo was provided to our quality team for investigation.Upon reviewing the photo, the protector is fitted on the vial and a leakage between the vial and protector was observed.All samples were evaluated, no defects or damage was identified, the protectors were properly fitted to a standard 32mm vial, and no leakages occurred.A device history review was performed for reported lot 1704009, 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, results were reviewed for this lot and found to be within specifications.Twelve retained samples of lot 1704009 were used for additional evaluation.All product was visually inspected and no defects were identified.Functional testing was performed, connecting the protector to a standard 32mm vial using the m12 assembly fixture and attaching a sample syringe and injector.In all cases the protectors were properly fitted to the vial, liquid inside the syringe could move to the vial and back to the syringe without issue, and no leaks were observed.Based on the investigation results, it was determined that the protector was not able to properly connect to the vial likely due to the vial cap which does not allow a secure fit for the protector onto the vial.The protector must be attached completely vertical.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.Complaints received for this device and defect will continue to be monitored by our quality team for signs of emerging trends.H3 other text : see section h.10.

• Brand Name: BD PHASEAL¿ PROTECTOR 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: 9272163
• Report Number: 3003152976-2019-00754
• Device Sequence Number: 11316996
• 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): 12/05/2019

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: 03/31/2022
• Device Catalogue Number: 515107
• Device Lot Number: 1704009
• Initial Date Received by Manufacturer: 10/18/2019
• Supplement Date Received by Manufacturer: 10/18/2019
• Initial Report FDA Received Date: 11/04/2019
• Supplement Report FDA Received Date: 12/05/2019
• 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