MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P14; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515100
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2021
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 p14 leaked.The following information was provided by the initial reporter: reconstitution of busulfan by the nurse in the department (because of the weekend).Wearing nitrile gloves, gown, plastic forearm protection.Bottle was pierced and preparation started with the secure system when i realized that drops of product were running down the bottle onto my hand.Tingling sensation: gloves removed, fingers immediately rinsed with warm water , hand washing with mild soap.Then another nurse (protection, double pair of gloves) took over for the end of the preparation.Disposal of the device in the blue chemo box.Consequences for the patient: none.
Additional Manufacturer Narrative
H.6.Investigation: no photos or physicals samples that display the reported issue were provided for investigation.A device history was performed and found no no-conformances related to the reported issue during production of batch 1807125.Four retained samples of the same lot were used for additional evaluation.The protectors were successfully connected to the vials, ensuring they fit properly.The product was evaluated and no damage or defects were observed.Functional testing was performed on the samples, no leak between the protector and vial was identified.Product undergoes visual and functional testing throughout manufacturing, including leakage testing.Results were reviewed for lot 1807125 and no issues related to the reported event were found.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.
Event or Problem Description
It was reported that protector p14 leaked.The following information was provided by the initial reporter: reconstitution of busulfan by the nurse in the department (because of the weekend).Wearing nitrile gloves + gown + plastic forearm protection.Bottle was pierced and preparation started with the secure system when i realized that drops of product were running down the bottle onto my hand.Tingling sensation: gloves removed, fingers immediately rinsed with warm water + hand washing with mild soap.Then another nurse (protection +++ double pair of gloves) took over for the end of the preparation.Disposal of the device in the blue chemo box.Consequences for the patient: none.

• Brand Name: PROTECTOR P14
• 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: 12081149
• Report Number: 3003152976-2021-00348
• Device Sequence Number: 19896119
• Product Code: ONB
• UDI-Device Identifier: 00382905151002
• UDI-Public: 00382905151002
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 07/15/2021

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: 06/30/2023
• Device Catalogue Number: 515100
• Device Lot Number: 1807125
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2021
• Supplement Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 06/28/2021
• Supplement Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1