MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE AUTOGUARD; INTRAVASCULAR CATHETER

Catalog Number 37262E

Device Problem Leak/Splash (1354)

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

Event Date 04/02/2024

Event Type  malfunction  

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Event Description

It was reported that bd insyte autoguard was leaking the following information was received by the initial reporter with the following verbatim it has been brought to our attention that either, lawson # 133750 iv ext set w/2 nedl free sites ref# 37262e or lawson # 104516 needle iv autoguard 22g ref # 382532 is leaking.They could not duplicate the issue with different items but are concerned.Just wanted you to be aware in case any other team members are reporting issues we are experience leaking with either item # 37262e or 382532 in the ed.Can you please help at xxxx? customer response for follow-up: 1.On or around 4-2-24 2.The dept did not know for sure which item was leaking for sure.3.Item # 133750 lot # is 24029188 & item # 104516 lot # 4037557.4.No harm was done.5.No 6.One occurrence.Could not duplicate leakage.7.I have the packaging of the two items but not the actual product.

• Brand Name: BD INSYTE AUTOGUARD
• Type of Device: INTRAVASCULAR CATHETER
• 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: 19208067
• MDR Text Key: 342006541
• Report Number: 1710034-2024-00371
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 10885403235276
• UDI-Public: (01)10885403235276
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022209
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/17/2024

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: Other
• Device Catalogue Number: 37262E
• Device Lot Number: 24029188
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/07/2024
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1