MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD WINGED; PERIPHERAL IV CATHETERS

Catalog Number	381512
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard winged shears during attempts to thread.The following information was provided by the initial reporter: stated by the account "i have a batch of 24gx0.75 iv caths that are malfunctioning when threading, they seem to be sticking and either kinking or shredding when threading.Lot number 3096295 this has happened several times.I used ultrasound yesterday to ensure i was in the vein , great blood return and when i advanced to thread it kinked on the needle and would not advance".
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.
Additional Manufacturer Narrative
Pr 9321770 follow up mdr for device evaluation: no photos or physical samples that display the reported condition were available for investigation.A device history record review was completed by our quality engineer team for provided material number 381512 and lot number 3096295.The review did not reveal any detected abnormalities during the production process that could have contributed to this incident 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.Based on the investigation results, an exact cause for this incident could not be identified.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see manufacturer narrative.
Event or Problem Description
It was reported that bd insyte autoguard winged shears during attempts to thread.The following information was provided by the initial reporter: stated by the account "i have a batch of 24gx0.75 iv caths that are malfunctioning when threading, they seem to be sticking and either kinking or shredding when threading.Lot number 3096295 this has happened several times.I used ultrasound yesterday to ensure i was in the vein , great blood return and when i advanced to thread it kinked on the needle and would not advance".

• Brand Name: BD INSYTE AUTOGUARD WINGED
• Common Device Name: PERIPHERAL IV CATHETERS
• 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: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18371022
• Report Number: 1710034-2023-01469
• Device Sequence Number: 7797449
• Product Code: FOZ
• UDI-Device Identifier: 30382903815129
• UDI-Public: (01)30382903815129
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K952861
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2024

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: Health Professional
• Device Expiration Date: 03/31/2026
• Device Catalogue Number: 381512
• Device Lot Number: 3096295
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 02/13/2024
• Initial Report FDA Received Date: 12/21/2023
• Supplement Report FDA Received Date: 02/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown