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

Catalog Number	515100
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 experienced an expansion chamber that burst.The following information was provided by the initial reporter: while using phaseal protectorp14 correctly, it split cytostatic with force to hdw¿s hands.When drawn drug from the bottle, the balloon exploded and all drug spilled.
Event or Problem Description
It was reported that the bd phaseal¿ protector p14 experienced an expansion chamber that burst.The following information was provided by the initial reporter: while using phaseal protectorp14 correctly, it split cytostatic with force to hdw¿s hands.When drawn drug from the bottle, the balloon exploded and all drug spilled.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 12-jul-2022.Investigation summary: one sample protector was returned to our quality engineer for investigation.Functional testing was completed, passing liquid through the injector into the vial, it was noted that the filter of the protector was saturated.No leakage outside of the protector was identified, however, liquid was observed inside the expansion chamber.If the protector is used more than once, liquid may accumulate and oversaturate the filter.This oversaturation would create a pressure which prevents proper air release to the expansion chamber.The same effect may occur if liquid accumulated within the internal face of the vial rubber stopper, overpressure can then create a leak into the expansion chamber.Products undergo visual and functional testing throughout manufacturing to ensure the quality and functionality of the device, including verification all critical dimensions are within specification and the expansion chamber is properly positioned and welded.As the lot involved in this incident is unknown, a device history review could not be performed.Based on the quality team's investigation, a root cause related to our manufacturing process cannot be identified at this time.H3 other text : see h10.

• 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: 14960470
• Report Number: 3003152976-2022-00313
• Device Sequence Number: 20180879
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• 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): 09/26/2022

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 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: 06/10/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 07/08/2022
• Supplement Report FDA Received Date: 10/04/2022
• 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