MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P50; INTRAVASCULAR ADMINISTRATION SET

Model Number	515105
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each additional lot number is as follows: medical device lot #: 2201118.Medical device expiration date: 31-dec-2026.Device manufacture date: 05-jan-2022.Medical device lot #: 2202133.Medical device expiration date: 31-jan-2027.Device manufacture date: 25-feb-2022.
Event or Problem Description
It was reported that the bd phaseal¿ protector p50 was leaking.The following information was provided by the initial reporter: is leaking during use.
Additional Manufacturer Narrative
H6: investigation summary no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lots 2201118 and 2202133, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Five retained samples of each lot were used for additional evaluation.Product was visually inspected and no issues were identified.Functional testing was performed, connecting the protector samples to a vial, injector, and syringe per the instructions for use provided with the product.In all cases the expansion chamber expanded properly, liquid was able to be drawn from the vial, and the product functioned as intended with no leakage into the expansion chamber.Product undergoes a series of testing during manufacturing to ensure the quality and functionality of the device.These tests include visual inspections along with leakage testing and flow rate, all records were reviewed for the reported lot and results were found to be acceptable.Based on our investigation we are not able to identify a root cause related to our manufacturing process at this time.
Event or Problem Description
It was reported that the bd phaseal¿ protector p50 was leaking.The following information was provided by the initial reporter: is leaking during use.

• Brand Name: BD PHASEAL¿ PROTECTOR P50
• 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: 15505811
• Report Number: 3003152976-2022-00449
• Device Sequence Number: 18176066
• Product Code: ONB
• UDI-Device Identifier: 30382905151058
• UDI-Public: (01)30382905151058
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2022

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 Model Number: 515105
• Device Catalogue Number: 515105
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 12/07/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 12/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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