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	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Initial reporter phone#: unknown.Initial reporter e-mail: 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 hycamtin leaked from between the bd phaseal¿ protector (p14) and vial during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about chemo leakage from the connection to the protector.According to the customer's report, during preparation of hycamtin, the fluid leakage from the connection between the protector and the vial was observed.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 14-nov-2022.H6: investigation summary: the product involved in the reported incident was provided to our quality team for investigation.Through visual inspection, no damage or defects was observed on the products.It was noted the protector needle penetrated the vial stopper incorrectly, piercing the stopper off center, the needle angled to one side.Functional testing was performed and no leakage outside the system was observed, however, fluid was noted to be inside the expansion chamber.Product undergoes visual and functional evaluations throughout the manufacturing process, including leakage testing and verification all critical dimensions are within specification.As lot information for this incident was not available, 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.
Event or Problem Description
It was reported that hycamtin leaked from between the bd phaseal¿ protector (p14) and vial during use.The following information was provided by the initial reporter, translated from japanese: "this is a report about chemo leakage from the connection to the protector.According to the customer's report, during preparation of hycamtin, the fluid leakage from the connection between the protector and the vial was observed.".

• 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: 15911799
• Report Number: 3003152976-2022-00539
• Device Sequence Number: 2480167
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: (01)00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 02/03/2023

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: 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: 11/07/2022
• Supplement Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/17/2023
• 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