MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P20-O MULTIPACK; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515065
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter facility: (b)(6).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 p20-o multipack leaked.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported by the sales rep that there is leakage through the membrane.
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: 7/29/2021.H.6.Investigation: ten unused protector samples along with ten unused injector samples were provided to our quality team for investigation.The product was visually inspected, no damage or defects were observed on any of the product.Moreover, one picture was received by the customer showing antiseptic isopropyl alcohol wipes used (according the verbatim of the complaint), for dabbing optima membrane.However; no pictures from claimed sample were received and therefore, no analysis on claimed sample involved in the complaint can be performed.No findings are available after the evaluation of picture received.A device history review was performed for lot 2103406, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.During manufacturing, leakage testing is performed, penetrating the protector ten times to verify if any leaks occur.Testing was reviewed for lot 2103406, all results were found to be within specification.Leakage testing was also performed on the ten samples that were provided.Using the returned sample injectors, the protector membrane was penetrated ten times, all samples meeting required specifications.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 p20-o multipack leaked.This occurred on 3 occasions.The following information was provided by the initial reporter: it was reported by the sales rep that there is leakage through the membrane.

• Brand Name: PROTECTOR P20-O MULTIPACK
• 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: 12097524
• Report Number: 3003152976-2021-00357
• Device Sequence Number: 14506832
• Product Code: ONB
• UDI-Device Identifier: 00382905150654
• UDI-Public: 00382905150654
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 05/31/2022
• Device Catalogue Number: 515065
• Device Lot Number: 2103406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Received by Manufacturer: 06/03/2021
• Supplement Date Received by Manufacturer: 09/13/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1