MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381454
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 10 bd insyte¿ autoguard¿ bc shielded iv catheters' tips frayed upon meeting resistance during use.The following information was provided by the initial reporter: "we have had an issue over the last few days with 16 gauge short ivs blowing.When looking at them today the catheter tip frays easily when it meets any kind of resistance.The 16 longs and the ivs that anesthesia uses (that do not allow blood return upon insertion) do not have the same issue.Additional information: i was here on wednesday when we noticed the issue and personally inspected two 16g ivs.The iv catheter tip is fraying when it meets resistance which is causing the vessels to blow during insertion.We had this happen with at least 10 on wednesday.".
Additional Manufacturer Narrative
H.3.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 10 bd insyte¿ autoguard¿ bc shielded iv catheters' tips frayed upon meeting resistance during use.The following information was provided by the initial reporter: "we have had an issue over the last few days with 16 gauge short ivs blowing.When looking at them today the catheter tip frays easily when it meets any kind of resistance.The 16 longs and the ivs that anesthesia uses (that do not allow blood return upon insertion) do not have the same issue additional information: i was here on wednesday when we noticed the issue and personally inspected two 16g ivs.The iv catheter tip is fraying when it meets resistance which is causing the vessels to blow during insertion.We had this happen with at least 10 on wednesday.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 18-may-2023.H6: investigation summary our quality engineer inspected the representative samples submitted for evaluation.Bd received six sealed 16ga x 1.16in.Insyte autoguard units from lot number 1328517.A penetration and drag test was performed on all units and all units met specifications.The catheters were visually inspected, and leak tested where all units passed inspection.The returned units provided for evaluation met and performed per the required manufacturing specifications.There was no physical/mechanical evidence to confirm and support a manufacturing process related issue for the failures stated in your report.A device history record review showed no non-conformances associated with this issue during the production of this batch.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16841909
• Report Number: 1710034-2023-00457
• Device Sequence Number: 12639494
• Product Code: FOZ
• UDI-Device Identifier: 00382903814541
• UDI-Public: 00382903814541
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• 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): 06/21/2023

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: 10/31/2024
• Device Catalogue Number: 381454
• Device Lot Number: 1328517
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2023
• Supplement Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 05/01/2023
• Supplement Report FDA Received Date: 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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 Sex: Unknown