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); Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/04/2021
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.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm was split, damaged, and had foreign matter.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported the actual equipment was soiled with blood and was discarded.The purple wings split, but the shaft of the introducer did not.
Additional Manufacturer Narrative
Investigation summary: a device history record review was completed by our quality engineer team for provided lot number 238454.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed and therefor the failure was not confirmed.
Event or Problem Description
It was reported that introducer introsyte-n 1.9f 1.9cm was split, damaged, and had foreign matter.This occurred on 2 occasions.The following information was provided by the initial reporter: it was reported the actual equipment was soiled with blood and was discarded.The purple wings split, but the shaft of the introducer did not.

• 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: 11918099
• Report Number: 1710034-2021-00457
• Device Sequence Number: 19033772
• Product Code: DYB
• UDI-Device Identifier: 00382903840212
• UDI-Public: 00382903840212
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 06/22/2021

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: 08/31/2023
• Device Catalogue Number: 384021
• Device Lot Number: 0238454
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2021
• Supplement Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1