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

Catalog Number 381523

Device Problems Retraction Problem (1536); Defective Component (2292)

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

Event Date 02/25/2024

Event Type  malfunction  

Event Description

It was reported that bd insyte autoguard winged needle did not retract.The following information was provided by the initial reporter: while starting intravenous on this patient the needle of the intravenous catheter would not retract.Sharp was safely discarded in biohazard sharps container after intravenous access was.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.E4.The initial reporter also notified the fda on 26-feb-2024.Medwatch report is (b)(4).D.The lot number 3228136 provided cannot be verified without a known material number.

Manufacturer Narrative

Additional information: material/lot number information added.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.The dhr for lot 3228136 have been reviewed.Subassembly lot 3228136 material 700iaw23 was built on afa line 5 from 25aug2023 through 01sep2023.Final lot was packaged on pkg line 10 from 29aug2023 through 01sep2023 for a total quantity of (b)(4).No related quality issues or process deviations were found.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: 19072322
• MDR Text Key: 340568904
• Report Number: 1710034-2024-00306
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903815234
• UDI-Public: (01)00382903815234
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 04/18/2024

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: 381523
• Device Lot Number: 3228136
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/09/2024
• Supplement Dates Manufacturer Received: 04/18/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1