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

Catalog Number 381533

Device Problems Leak/Splash (1354); Material Puncture/Hole (1504)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/18/2024

Event Type  malfunction  

Manufacturer Narrative

The lot number 3277650 provided cannot be verified in association with the reported material number.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.

Event Description

It was reported that bd insyte autoguard winged hole in the catheter.The following information was provided by the initial reporter: after the nurse placed it, it started leaking blood.At first the nurse thought it was leaking from around the insertion site, but when he flushed the iv, it squirted blood/saline vertically out of the catheter at the insertion point.There was a hole in the catheter.The nurse removed the iv and placed a new on in the other arm.No issue with that one.No patient harm.

Event Description

No additional information.

Manufacturer Narrative

Additional information: lot number.Investigation results: the reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.Dhr for lot number 3277650 has been reviewed.This lot was built and packaged on nfa line 2 from 19oct2023 through 21oct2023 for a total quantity of (b)(4) units.No related quality issues or deviations were found during the manufacture of the subassembly batch.This complaint type will continue to be trended within the post market surveillance process and any determined escalation will be managed there.

• Brand Name: BD INSYTE AUTOGUARD WINGED
• Type of Device: 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: 19058770
• MDR Text Key: 340465002
• Report Number: 1710034-2024-00296
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815333
• UDI-Public: (01)00382903815333
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 381533
• Device Lot Number: 3277650
• Initial Date Manufacturer Received: 03/18/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/07/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1