MAUDE Adverse Event Report: BECTON DICKINSON, S.A. PROTECTOR P13-O; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	515060
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/13/2021
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.(b)(4).
Event or Problem Description
It was reported that protector p13-o was damaged.The following information was provided by the initial reporter: material no.: 515060, batch no.: 2008404.It was reported that a piece broke off of the p13-o.Per pir: p13-o had a piece break off - it was noticed when the protector was placed in the assembly fixture the technician noticed a piece fall.They believe it was the plastic spike.
Event or Problem Description
It was reported that protector p13-o was damaged.The following information was provided by the initial reporter: material no.: 515060, batch no.: 2008404.It was reported that a piece broke off of the p13-o.Per pir: p13-o had a piece break off - it was noticed when the protector was placed in the assembly fixture the technician noticed a piece fall.They believe it was the plastic spike.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-03-29.Investigation summary: one sample was provided to our quality team for investigation.Through visual inspection, the spike was observed to broken and the tip of the optima protector was damaged.Using magnification, the product was evaluated, not observing any bubbles or other damage that could have contributed to the observed defect.A device history review was performed for lot 2008404, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Three retained samples of the same lot were used for additional evaluation.The product was visually inspected and no defects were observed within any of the samples.Functional testing was performed, connecting each protector to a vial, the spike penetrated the vial stopper properly and liquid was properly aspirated without issue, no damage to the spike occurred.Product undergoes inspections throughout the manufacturing process to ensure the quality and functionality of the device.All results were reviewed for lot 2008404 and results were found to be acceptable, no issues related to the reported defect were identified.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.

• Brand Name: PROTECTOR P13-O
• 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: 11274737
• Report Number: 3003152976-2021-00060
• Device Sequence Number: 3543039
• Product Code: ONB
• UDI-Device Identifier: 00382905150609
• UDI-Public: 00382905150609
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K181221
• Number of Events Summarized: 1
• Summary Report (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): 04/06/2021

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: Lay User/Patient
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 515060
• Device Lot Number: 2008404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 01/13/2021
• Supplement Date Received by Manufacturer: 04/06/2021
• Initial Report FDA Received Date: 02/03/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1