MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR P13-O; INTRAVASCULAR ADMINISTRATION SET

Model Number	515060
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd phaseal¿ protector p13-o experienced foreign matter, contaminated.The following information was provided by the initial reporter: this looks like little white particles that are on the cstd itself.I¿ve attached a photograph of the injector where this has happened.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd phaseal¿ protector p13-o experienced foreign matter, contaminated.The following information was provided by the initial reporter: this looks like little white particles that are on the cstd itself.I¿ve attached a photograph of the injector where this has happened.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 30-jun-2023.H6: investigation summary sample and photo received by our quality team for investigation.Upon visual evaluation, foreign matter is observed on the film of expansion chamber.Foreign matter is mainly composed burnt material.A device history review was performed for reported lot 2201414, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Three retained samples were used for additional evaluation.No damage or other defects was observed on any of the product.Functional testing was performed, connecting the injector to a sample syringe, protector and vial according to the instructions for use.Liquid was aspirated from the vial, disconnecting the injector from the protector and repeating the process three times.In all cases, the product functioned properly and there were no issues observed between the connection of the injectors and protector.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 the available information, possible root cause is associated with burnt material at the film sealing station in the expansion chamber.H3 other text : see h10.

• Brand Name: BD PHASEAL¿ PROTECTOR P13-O
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer (Section G): BECTON DICKINSON, S.A.; cr mequinenza; s/n; fraga, huesca 22520 ; SP 22520
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16695314
• Report Number: 3002682307-2023-00092
• Device Sequence Number: 5669888
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: (01)00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• 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): 06/30/2023

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 Expiration Date: 12/31/2023
• Device Model Number: 515060
• Device Catalogue Number: 515060
• Device Lot Number: 2201414
• 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: 03/17/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 04/06/2023
• Supplement Report FDA Received Date: 07/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/03/2022
• 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