MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. INTRODUCER INTROSYTE-N 1.9F 1.9CM; CATHETER INTRODUCER

Catalog Number	384021
Medical Device Problem Codes	Break (1069); Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
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 introducer introsyte-n 1.9f 1.9cm sheath broke.The following information was provided by the initial reporter: material no: 384021, batch no: 0183797.It was reported that the item #: 0183797 peel away sheath broke away at the top.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm sheath broke.The following information was provided by the initial reporter: material no: 384021.Batch no: 0183797.It was reported that the item 0183797 peel away sheath broke away at the top.
Additional Manufacturer Narrative
Investigation summary: our quality engineer inspected the sample submitted for evaluation.The reported issue was confirmed upon inspection of the sample.Bd was not able to confirm that bd¿s manufacturing process was the root cause of the failure.It is more likely that the cause of the failure is associated with our supplier¿s process and they have ben notified of the failure.Quality records have been consulted for tracking and trending purposes and this was the first occurrence of this failure mode, which means issues like this are rare.A device history record review showed no non-conformances associated with this issue during the production of this batch.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: INTRODUCER INTROSYTE-N 1.9F 1.9CM
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• MDR Report Key: 11788066
• Report Number: 1710034-2021-00384
• Device Sequence Number: 14468313
• Product Code: DYB
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K020834
• 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): 06/16/2021

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: 384021
• Device Lot Number: 0183797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 04/15/2021
• Supplement Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 07/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1