MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ CONNECTOR LUER LOCK C35; INTRAVASCULAR ADMINISTRATION SET

Model Number	515200
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2022
Type of Reportable Event	Malfunction
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 prior to using a bd phaseal¿ connector luer lock c35, foreign matter was observed in the unit package.The following information was provided by the initial reporter: hair sealed into the packaging.
Event or Problem Description
It was reported that prior to using a bd phaseal¿ connector luer lock c35, foreign matter was observed in the unit package.The following information was provided by the initial reporter: hair sealed into the packaging.
Additional Manufacturer Narrative
H6: investigation summary: one photo was provided to our quality team for investigation.Upon visually inspecting the photo, a hair was observed inside the blister pack.A device history review was performed for the reported lot 2108208, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Manufacturing for this product is performed in a clean room which is kept under a positive pressure to reduce the chance of foreign matter.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.All individuals are required to follow proper gowning procedures before entering the room, including hair protection.While we could not identify a direct issue, the root cause of this incident is due to personnel not following the proper gowning procedure.

• Brand Name: BD PHASEAL¿ CONNECTOR LUER LOCK C35
• 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: 13967572
• Report Number: 3003152976-2022-00125
• Device Sequence Number: 4882922
• Product Code: ONB
• UDI-Device Identifier: 30382905152000
• UDI-Public: 30382905152000
• 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): 04/22/2022

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 Expiration Date: 07/31/2025
• Device Model Number: 515200
• Device Catalogue Number: 515200
• Device Lot Number: 2108208
• 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: 03/14/2022
• Supplement Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 03/31/2022
• Supplement Report FDA Received Date: 05/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2021
• 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