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

Catalog Number 381433

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Vessel Or Plaque, Device Embedded In (1204); Pain (1994)

Event Date 08/09/2019

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 during insertion the catheter split with a bd insyte¿ autoguard¿ shielded iv catheter.This occurred on 2 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: when inserting the cannula, tip split and got caught in the vein.This was very painful for the patient.

Event Description

It was reported that during insertion the catheter split with a bd insyte¿ autoguard¿ shielded iv catheter.This occurred on 2 separate occasions, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: when inserting the cannula, tip split and got caught in the vein.This was very painful for the patient.

Manufacturer Narrative

H.6.Investigation: bd received 20 insyte autoguard 20 gauge units from lot 8184948 for evaluation.A review of the device history record was performed for the reported lot and no related quality issues were found during production.Our quality engineer visually inspected the returned units and observed damage along the catheter tubing starting at the tip and going down with the first unit.The remaining 19 units were inspected and no damage was observed and the catheter tips were found to be acceptable and within product specifications.Based off the visual inspection the engineer was able to verify the reported defect with the first unit.No defects were found with the remaining.Unfortunately, the engineer was unable to determine a definitive root cause for the observed damage.The unit was received used and out of its original package therefore it is unknown if the damage was caused by the manufacturing process or at the user environment prior/during usage.H3 other text : see h.10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ 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: 8931666
• MDR Text Key: 157461475
• Report Number: 1710034-2019-00928
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903814337
• UDI-Public: 30382903814337
• Combination Product (y/n): N
• PMA/PMN Number: K952861
• 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: 09/26/2019

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: 06/30/2021
• Device Catalogue Number: 381433
• Device Lot Number: 8184948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2019
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/09/2019
• Supplement Dates FDA Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other