MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. PROTECTOR P53; INTRAVASCULAR ADMINISTRATION SET

Model Number	515107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 p53 leaked on 25 occasions.The following information was provided by the initial reporter: leakage between protector and vial.No patient involved.
Event or Problem Description
It was reported that protector p53 leaked on 25 occasions.The following information was provided by the initial reporter: leakage between protector and vial.No patient involved.
Additional Manufacturer Narrative
H6: investigation summary: 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 1704009.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 and verification that altricial dimensions are within specification.Results were reviewed for lot 1704009 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.The protector must be attached completely vertical to the vial during assembly.The m12 assembly fixture is recommended to ease the connection of the protector to the vial.

• Brand Name: PROTECTOR P53
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 10841542
• Report Number: 3003152976-2020-00506
• Device Sequence Number: 19646746
• Product Code: ONB
• UDI-Device Identifier: 30382905151072
• UDI-Public: 30382905151072
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 03/31/2022
• Device Model Number: 515107
• Device Catalogue Number: 515107
• Device Lot Number: 1704009
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 11/15/2020
• Supplement Report FDA Received Date: 02/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1