MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. INTROSYTE AUTOGUARD 26G INTRO ONLY; CATHETER INTRODUCER

Model Number	384008
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the introsyte autoguard 26g intro only sheath broke off completely.The following information was provided by the initial reporter: as i went to peel the sheath, one side of the sheath broke off completely right at the purple part of the introducer.
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Date of birth: patient¿s birthday was not provided, (b)(6) 2023 was used based on age of patient.The initial reporter also notified the fda on 04-apr-2023.Medwatch report # (b)(4).
Event or Problem Description
No additional information.
Additional Manufacturer Narrative
(b)(4).Follow up mdr for device evaluation: it was reported one side of the sheath broke off completely right at the purple part of the introducer.To aid in the investigation, one picture was received for evaluation by our quality team.The defect can be observed in the photo.There is no activity or operation during the manufacturing process that this defect could be attributed to; therefore, the failure mode is associated to the supplier.The supplier investigation concluded processes outside of the supplier were likely the contributor to the failure mode.A device history record review was completed for provided material number: 384008, lot: 2060080.The review revealed there were no internal rejects related to the reported issue during this order.According to control plan for the manufacturing process, this lot was accepted and meet acceptance criteria.To date, there have been no other similar events reported for this lot.Based on the investigation, bd was able to confirm the customer's indicated failure mode.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: INTROSYTE AUTOGUARD 26G INTRO ONLY
• Common Device Name: CATHETER INTRODUCER
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16802284
• Report Number: 9610847-2023-00092
• Device Sequence Number: 15236934
• Product Code: DYB
• UDI-Device Identifier: 50382903840088
• UDI-Public: (01)50382903840088
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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): 03/14/2024

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: 02/28/2025
• Device Model Number: 384008
• Device Catalogue Number: 384008
• Device Lot Number: 2060080
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 07/10/2023
• Initial Report FDA Received Date: 04/24/2023
• Supplement Report FDA Received Date: 03/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/30/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Sex: Female
• Patient Weight: 2 KG