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

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd phaseal¿ protector p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: after attaching the second vial to the protector, the ide turned the system horizontal to inject air into the second vial.At this point, the ide noticed a leak of the product between the vial and the protector.The nurse recovered the prescribed amount of product.
Additional Manufacturer Narrative
Medical device lot #: 10301 was reported, however, this is not a lot # manufactured for the reported catalog #.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 05-dec-2022.H6: investigation summary: one protector connected to a vial was provided to our quality team for investigation.Functional testing was performed, and no leakage between the protector and vial was observed.Further evaluation identified the protector needle penetrated the vial off center and staining was observed on the vial stopper, indicating a leak may have occurred during use of the product.Product undergoes visual and functional evaluations throughout the manufacturing process, including leakage testing and verification all critical dimensions are within specification.As a valid lot was not provided, a device history review could not be performed.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.This incident was likely a result of the protector being improperly attached, causing the needle to penetrate off center.The protector must be attached completely vertical to the vial.
Event or Problem Description
It was reported while using bd phaseal¿ protector p14 leakage occurred.There was no report of patient impact.The following information was provided by the initial reporter, translated from french to english: after attaching the second vial to the protector, the ide turned the system horizontal to inject air into the second vial.At this point, the ide noticed a leak of the product between the vial and the protector.The nurse recovered the prescribed amount of product.

• Brand Name: BD PHASEAL¿ PROTECTOR P14
• Common Device Name: 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: 15789556
• Report Number: 3003152976-2022-00510
• Device Sequence Number: 12168091
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K123213
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2023

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: Health Professional
• Device Catalogue Number: 515100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 01/23/2023
• Initial Report FDA Received Date: 11/14/2022
• Supplement Report FDA Received Date: 02/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown