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

Catalog Number 382512

Device Problem Retraction Problem (1536)

Patient Problem Tissue Damage (2104)

Event Date 05/23/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle was jammed and the bd insyte¿ autoguard¿ bc shielded iv catheter would not snap off, resulting in the patient's vein blowing up.The following information was provided by the initial reporter: "needle was jamming and the catheter would not snap off.The incident blew up the patients vein.".

Event Description

It was reported that the needle was jammed and the bd insyte¿ autoguard¿ bc shielded iv catheter would not snap off, resulting in the patient's vein blowing up.The following information was provided by the initial reporter: "needle was jamming and the catheter would not snap off.The incident blew up the patients vein.".

Manufacturer Narrative

Investigation: bd received 21 unused 24 gauge insyte autoguard blood control units from lot 9064879 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no physical/mechanical damage to any of the tubing for the units.Next, the engineer checked the tip adhesion by manually rotating the clear barrels 360 degrees and no issues were found.Finally, a flashback test was performed for the returned units and flashback was seen quickly with no obstructions.Based off the visual inspection and testing the engineer was unable to verify any defects.Since no defects were observed a definitive root cause could not could not be determined.

• 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: 8678900
• MDR Text Key: 147444166
• Report Number: 1710034-2019-00608
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903825128
• UDI-Public: 30382903825128
• Combination Product (y/n): N
• PMA/PMN Number: K110443
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2022
• Device Catalogue Number: 382512
• Device Lot Number: 9064879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2019
• Initial Date Manufacturer Received: 05/23/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other