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

Catalog Number 381412

Device Problem Break (1069)

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

Event Date 12/13/2023

Event Type  malfunction  

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter was cracked and leaking.The following information was provided by the initial reporter: "last night an rn started an iv on a scalp vein on an infant.She states she had flash instantly and slid right in, no re-insertion or manipulation needed.It drew blood fine but would not flush.In troubleshooting, they found that the catheter was cracked and leaking at the base, where the catheter attaches to the yellow hub.Of course, they had to remove this line and stick again.".

Manufacturer Narrative

H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

Investigation results: three photos were provided for evaluation.All the photos were the same.The photos displayed a 24-gauge catheter/adapter assembly attached to a syringe.The first photo displayed a droplet coming from the nose of the catheter/adapter.The second photo displayed two droplets at the nose of the catheter/adapter.Although the photo did not provide sufficient evidence to identify the defect, the droplets indicate the likely presence of a breach in the device.Leakage can be the result of catheter damage, which can occur during manufacturing from either needle puncture damage or assembly damage.100% vision inspections help mitigate needle puncture damage.Damage can also occur during insertion if the needle is inadvertently reinserted into the catheter.Investigation conclusion(s): without the physical sample, "catheter damage" could not be confirmed; however, ¿leakage at adapter/tubing junction¿ was confirmed due to the presence of liquid at the junction between the catheter adapter and catheter tubing.Probable root cause: not determined.

Event Description

No additional information.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• 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: 18519242
• MDR Text Key: 332939017
• Report Number: 1710034-2023-01537
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903814121
• UDI-Public: (01)00382903814121
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

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: 381412
• Device Lot Number: 1356149
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/20/2023
• Initial Date FDA Received: 01/16/2024
• Supplement Dates Manufacturer Received: 02/05/2024
• Supplement Dates FDA Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1