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

Catalog Number 381912

Device Problem Defective Component (2292)

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

Event Date 03/11/2024

Event Type  malfunction  

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 Description

It was reported that bd insyte autoguard winged unable to connect cap to adapter.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2024, the nurse followed the doctor's orders for the child to draw blood for laboratory tests, using a straight indwelling needle to puncture, after successful puncture, ready to connect the heparin cap, found that there is a defect in the connecting port of the indwelling needle, and the heparin cap can not be connected, the incident immediately after the use of 2.5ml syringe connected to the indwelling needle to draw blood, and after the completion of the drawing of blood, the indwelling needle was withdrawn.No impact on children's health.

Manufacturer Narrative

Investigation results: no photographic evidence or physical samples were accessible to investigate the reported condition.Our quality engineer team conducted a comprehensive review of the device history record for the provided material number 381912 and lot number 3248257.This review did not uncover any abnormalities during the production process that could have caused this defect, and all quality tests were found to be within the specified standards.Unfortunately, the exact cause of this incident could not be determined based on the information available.We will continue to track and analyze complaints related to this device and the reported condition in order to identify any emerging trends.

Event Description

No additional information.

• 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: 19102699
• MDR Text Key: 340811456
• Report Number: 1710034-2024-00331
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903819126
• UDI-Public: (01)00382903819126
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/07/2024

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: 381912
• Device Lot Number: 3248257
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2024
• Initial Date FDA Received: 04/13/2024
• Supplement Dates Manufacturer Received: 05/07/2024
• Supplement Dates FDA Received: 05/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/07/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1