MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL PROTECTORS P53

Model Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2020
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 the bd phaseal¿ protectors p53 experienced leakage between the protector and vial during use.The following information was provided by the initial reporter: leakage of a chemo between the protector and the vial occurred.The drug used was cisplatin.Assembly fixture was not used.There was no use in clinical settings.
Event or Problem Description
It was reported that the bd phaseal¿ protectors p53 experienced leakage between the protector and vial during use.The following information was provided by the initial reporter: leakage of a chemo between the protector and the vial occurred.The drug used was cisplatin.Assembly fixture was not used.There was no use in clinical settings.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-09-14.H6: investigation summary one sample was returned to our quality engineer for investigation.The product was visually inspected, no issues were observed on the protector membrane.It was noted that the protector did not properly fit onto the vial, the protector clips are longer than the height of the vial neck, which can lead to a leak between the protector and vial.Functional testing was performed and liquid inside the syringe could successfully move to the vial and back to the syringe without issue and no leakage was observed.Leakage testing is performed for all lots during manufacturing to ensure the quality of the membrane.A device history review was performed for lot 1604018, no deviations or non-conformances were identified during the manufacturing process that could have contributed to these issues.While we could not identify a direct issue and no leak was identified during our evaluation, the leakage may have occurred during use as a result of the protector not securely fitting onto the vial.The protector must be attached completely vertical when attaching onto the vial.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.

• Brand Name: BD PHASEAL PROTECTORS P53
• Common Device Name: PHASEAL PROTECTOR
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 10616388
• Report Number: 3003152976-2020-00428
• Device Sequence Number: 14424538
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 12/03/2020

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: 03/31/2021
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: 1604018
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• Initial Date Received by Manufacturer: 09/08/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 10/01/2020
• Supplement Report FDA Received Date: 12/05/2020
• 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