MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ PROTECTOR (P55); INTRAVASCULAR ADMINISTRATION SET

Model Number	515117
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.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 two silicon-like foreign matters were observed in the expansion chamber of bd phaseal¿ protector (p55).The following information was provided by the initial reporter: this is a report about foreign matters in expansion chamber of protector.According to the customer's report, two silicon-like foreign matters were observed in the expansion chamber.It might be in the filter.The hcp noticed it in use but decided it would not affect performance and continued.
Event or Problem Description
It was reported that two silicon-like foreign matters were observed in the expansion chamber of bd phaseal¿ protector (p55).The following information was provided by the initial reporter: this is a report about foreign matters in expansion chamber of protector.According to the customer's report, two silicon-like foreign matters were observed in the expansion chamber.It might be in the filter.The hcp noticed it in use but decided it would not affect performance and continued.
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, loose filter inside the expansion hood of the protector is observed.The protector itself, had its filter and filter cover well assembled, but this one appeared loose between the bell and the film of the bell.This is a cosmetic defect, and the product functionality is not impacted.A device history review was performed for reported lot 2204113, no deviations or non-conformances related to the reported issue were identified during the manufacturing process.Five retained samples were used for additional evaluation.No damage or other defects was observed on any of the product.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 the assembly process.

• Brand Name: BD PHASEAL¿ PROTECTOR (P55)
• 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 ; 8448235433
• MDR Report Key: 16882375
• Report Number: 3003152976-2023-00162
• Device Sequence Number: 15269416
• Product Code: ONB
• UDI-Device Identifier: 30382905151171
• UDI-Public: (01)30382905151171
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K130197
• 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 Model Number: 515117
• Device Catalogue Number: 515117
• Device Lot Number: 2204113
• 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: 04/14/2023
• Supplement Date Received by Manufacturer: 06/30/2023
• Initial Report FDA Received Date: 05/05/2023
• Supplement Report FDA Received Date: 07/21/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2022
• 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