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 Known Impact Or Consequence To Patient (2692)
Date of Event	10/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter facility name: (b)(6).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 an unspecified number of protector p21s experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: the customer saw small pieces of the membrane in 3 bottles (coring).It happens with vancomycin 1g from pharmacy.
Event or Problem Description
It was reported that an unspecified number of protector p21s experienced foreign matter contamination which was noted during use.The following information was provided by the initial reporter: the customer saw small pieces of the membrane in 3 bottles (coring).It happens with vancomycin 1g from pharmacy.
Additional Manufacturer Narrative
Investigation summary: no photos or physical samples that display the reported condition were available for investigation.A device history review was performed for reported lot 1907146, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.While phaseal needles are designed to reduce coring, there are several factors that may impact coring tendency.Coring from the membrane may occur due to fragmentation caused by multiple injections or excessive welding of the membrane.Fragmentation testing is performed during manufacturing, results were reviewed for the reported lot and found to be acceptable.Coring of the rubber stopper may result depending on the stopper quality, the design and dimensions of the needles used, or if a poor connection of the protector occurs.Based on the available information we are not able to identify a definitive root cause at this time.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.Complaints received for this device and reported issue will continue to be tracked and trended for future occurrence.A capa ((b)(4)) was already open, prior to the investigation of the complaint to assess the defect.

• 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: 9285523
• Report Number: 3003152976-2019-00766
• Device Sequence Number: 2335675
• Product Code: ONB
• UDI-Device Identifier: 30382905151027
• UDI-Public: 30382905151027
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K123213
• 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): 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2024
• Device Catalogue Number: 515102
• Device Lot Number: 1907146
• Initial Date Received by Manufacturer: 10/22/2019
• Supplement Date Received by Manufacturer: 10/22/2019
• Initial Report FDA Received Date: 11/06/2019
• Supplement Report FDA Received Date: 12/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other