MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTORS 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	09/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that during use of the bd phaseal¿ protectors p53 there was leakage between protector and vial.This occurred on 25 separate occasions but the date/time is unknown.The following information was provided by the initial reporter: leakage between protector and vial.No patient involved.
Additional Manufacturer Narrative
H.6.Investigation: one physical sample and one photo was returned to our quality team for investigation.Upon inspection of the sample, liquid inside the syringe could move to the vial and back into the syringe without issue, however, a leak was observed.Further testing was conducted and after properly reconnecting the vial and protector, no sign of leakage occurred.A device history was performed and found no non-conformances related to the reported issue during production of batch 1704009.Based on the investigation results, it was determined that the protector was not securely connected to the vial which resulted in the leak reported.The protector must be attached completely vertical to the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.H3 other text : see h.10.
Event or Problem Description
It was reported that during use of the bd phaseal¿ protectors p53 there was leakage between protector and vial.This occurred on 25 separate occasions but the date/time is unknown.The following information was provided by the initial reporter: leakage between protector and vial.No patient involved.

• 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: 9134841
• Report Number: 3003152976-2019-00676
• Device Sequence Number: 11410302
• 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): 11/12/2019

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: Health Professional
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 515107
• Device Lot Number: 1704009
• Initial Date Received by Manufacturer: 09/12/2019
• Supplement Date Received by Manufacturer: 09/12/2019
• Initial Report FDA Received Date: 09/30/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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