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

Catalog Number	381437
Medical Device Problem Codes	Material Frayed (1262); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd insyte autoguard frays and splits during insertion attempts.The following information was provided by the initial reporter: i am being told by my staff that they are finding the bd iv catheters utilized for the ultrasound placed ivs.Many users have said they are finding the catheters are "fraying" and "splitting" upon insertion.16 nov 2023 1.Patient status-alive 2.Sample status?-physical sample available or not available? not available 3.Any adverse event or serious injury reported to patient or healthcare professional? no 4.Was there a delay of, or change in, the course of treatment due to the event? no 5.Are you able to further describe the issue of catheter sticking during insertion? cather is not sticking, it is breaking.6.-was there any damage noticed on catheter valve? no 7.Was there any patient involvement? insertion to patient was occurring when the catheter broke.
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.If additional information becomes available, a supplemental report will be filed.
Additional Manufacturer Narrative
Investigation results: the complaint that the catheters were fraying and splitting upon insertion could not be confirmed from the photograph that was provided for investigation.The photo showed the top web unit label from a 20g x 1.16" insyte autoguard product.The lot number on the packaging was 0832353 and the expiration date was 2023-01-31.The customer indicated that lot #3129611 was affected.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.Investigation conclusion(s): the complaint of ¿catheter tip integrity¿ was not confirmed.Probable root cause(s): a root cause cannot be determined without a confirmed defect.
Event or Problem Description
No additional information.

• Brand Name: BD INSYTE AUTOGUARD
• 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: 18166786
• Report Number: 1710034-2023-01320
• Device Sequence Number: 17777579
• Product Code: FOZ
• UDI-Device Identifier: 00382903814374
• UDI-Public: (01)00382903814374
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2024

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: 04/30/2026
• Device Catalogue Number: 381437
• Device Lot Number: 3129611
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2023
• Supplement Date Received by Manufacturer: 01/21/2024
• Initial Report FDA Received Date: 11/18/2023
• Supplement Report FDA Received Date: 01/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown