MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P21; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515102
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	04/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that protector p21 had foreign matter.The following information was provided by the initial reporter: before using the phaseal protector the pharmacist noticed a hair in the sterile packaging.The product was therefore not used.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 6/28/2021.H.6.Investigation: two samples and one photo were provided to our quality team for investigation.One samples received was unused and no contamination was observed when inspected.Upon evaluation of the second sample and photo, a hair was observed between the expansion bladder and film.Retained samples of lot 2011109 were used for additional evaluation.All product was inspected, no hair or other foreign matter was observed.A device history review was performed for the reported lot 2011109, 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.
Event or Problem Description
It was reported that protector p21 had foreign matter.The following information was provided by the initial reporter: before using the phaseal protector the pharmacist noticed a hair in the sterile packaging.The product was therefore not used.

• Brand Name: PROTECTOR P21
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• MDR Report Key: 11899335
• Report Number: 3003152976-2021-00299
• Device Sequence Number: 3755053
• Product Code: ONB
• UDI-Device Identifier: 00382905151026
• UDI-Public: 00382905151026
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2021

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: 10/31/2025
• Device Catalogue Number: 515102
• Device Lot Number: 2011109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 04/29/2021
• Supplement Date Received by Manufacturer: 08/11/2021
• Initial Report FDA Received Date: 05/28/2021
• Supplement Report FDA Received Date: 08/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1