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

Catalog Number	381444
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd insyte autoguard catheter has a hole that leaks.The following information was provided by the initial reporter: we had an issue with the bd insyte autoguard 18ga x 1.16in catheter.After placing an iv in the patient the site was found to be leaking and a hole was discovered in the catheter itself.We have saved the catheter and packaging.
Event or Problem Description
Additional information: there was no patient harm.The iv was removed and a new iv was placed.
Additional Manufacturer Narrative
Additional information: details added to b5.Investigation results: the complaint of a hole in the catheter was confirmed; however, the root cause could not be determined.One 18g insyte autoguard device from lot number 3214009 was provided for investigation.The sample exhibited evidence of use.The needle was received fully retracted.A v-shaped puncture was observed in the catheter tubing, which was consistent with needle puncture damage.This type of damage can occur during assembly or use of the device.Manufacturing controls are in place to mitigate the occurrence of this type of failure.The ifu indicates to not reinsert the needle into the catheter during the insertion process as damage may occur.Due to the evidence of use, it is possible that the catheter was punctured during the insertion process; however, the root cause could not be determined.A review of the inspection records and quality/manufacturing controls for the implicated lot indicated no issues with the manufacturing process.The complaint has been documented and will continue to be monitored as part of ongoing efforts to identify potential manufacturing related issues.

• 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: 18949963
• Report Number: 1710034-2024-00208
• Device Sequence Number: 7348273
• Product Code: FOZ
• UDI-Device Identifier: 00382903814442
• UDI-Public: (01)00382903814442
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2024

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: 07/31/2026
• Device Catalogue Number: 381444
• Device Lot Number: 3214009
• 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: 02/28/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 03/21/2024
• Supplement Report FDA Received Date: 06/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown