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

Catalog Number 381033

Device Problems Leak/Splash (1354); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly.Report also states that after catheter placement, leakage occurred and the iv catheter had to be replaced.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Investigation summary: device/batch history record review could not be conducted as the lot number associated with the investigation is unknown.Visual analysis: observations and testing: received one used 20ga catheter/adapter iag bc assembly along with a fully retracted needle-barrel assembly and a miscellaneous extension set.Visual/microscopic examination: the needle was received fully retracted within the safety barrel.The needle was placed into the out position and no damage was found.No traces of adhesive were present, and the needle successfully retracted upon pushing the white button.Damage on the inner wall of the adapter was observed.There were no holes, splits, kinks, bends or wrinkles in the catheter tubing.Water-leak test: the lab supplied male slip luer test fitting was connected to the end of the adapter.The water/air leak test was performed.Damage on the outer threads of the adapter was observed causing leakage during testing.Although a definite source that caused the damage on the adapter could not be determined, it could have happen anywhere on the line where a machine part contacts the female luer of the adapters.A formal corrective action will not be initiated at this time.Customer complaint trends are evaluated on a monthly basis.If the trend of a specific type of complaint warrants a formal corrective action, resources will be assigned at that time.

Event Description

It was reported that the safety mechanism on a bd insyte¿ autoguard¿ bc shielded iv catheter failed to function properly.Report also states that after catheter placement, leakage occurred and the iv catheter had to be replaced.There was no report of exposure, injury or medical interventions.

• 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
• MDR Report Key: 7603560
• MDR Text Key: 111654973
• Report Number: 1710034-2018-00277
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 381033
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/28/2018
• Date Manufacturer Received: 05/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other