MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 381033

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 06/03/2022

Event Type  malfunction  

Manufacturer Narrative

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 when the bd insyte¿ autoguard¿ shielded iv catheter 20ga x 1.0in was inserted, the blood control valve did not work resulting in leakage.This occurred 2 times.The following information was provided by the initial reporter: there was no adverse event for the nurses, it resulted in a blood leak from the catheter and therefore a loss of time for them.When the catheter was inserted, the blood flowed back into the catheter despite the anti-reflux device on the equipment.Even after rinsing the catheter, the blood would flow back into the tubing.This problem occurred on 2 occasions.

Manufacturer Narrative

The following field was corrected due to additional information: b.5.Describe event or problem: it was reported that the when the bd insyte¿ autoguard¿ shielded iv catheter 20ga x 1.0in was inserted, the blood control valve did not work resulting in leakage.This occurred 1 time.The following information was provided by the initial reporter: there was no adverse event for the nurses, it resulted in a blood leak from the catheter and therefore a loss of time for them.When the catheter was inserted, the blood flowed back into the catheter despite the anti-reflux device on the equipment.Even after rinsing the catheter, the blood would flow back into the tubing.H3 other text : see h.10.

Event Description

It was reported that the when the bd insyte¿ autoguard¿ shielded iv catheter 20ga x 1.0in was inserted, the blood control valve did not work resulting in leakage.This occurred 1 time.The following information was provided by the initial reporter: there was no adverse event for the nurses, it resulted in a blood leak from the catheter and therefore a loss of time for them.When the catheter was inserted, the blood flowed back into the catheter despite the anti-reflux device on the equipment.Even after rinsing the catheter, the blood would flow back into the tubing.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 20-sep-2022.H6: investigation summary: bd received 29 insyte autoguard blood control pro units from lot 2018397 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 visible defects.Next, the units were tested for leakage.No leaks or bubbles were observed during testing.Therefore, based off the visual inspection and testing the engineer was unable to verify the reported defect.Since no defects were observed during inspection the engineer was unable to determine a definitive root cause for this issue.

Event Description

It was reported that the when the bd insyte¿ autoguard¿ shielded iv catheter 20ga x 1.0in was inserted, the blood control valve did not work resulting in leakage.This occurred 1 time.The following information was provided by the initial reporter: there was no adverse event for the nurses, it resulted in a blood leak from the catheter and therefore a loss of time for them.When the catheter was inserted, the blood flowed back into the catheter despite the anti-reflux device on the equipment.Even after rinsing the catheter, the blood would flow back into the tubing.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 20GA X 1.0IN
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15009222
• MDR Text Key: 304694716
• Report Number: 1710034-2022-00362
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K201075
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/20/2022

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: 381033
• Device Lot Number: 2018397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/13/2022
• Initial Date FDA Received: 07/13/2022
• Supplement Dates Manufacturer Received: 06/13/2022; 09/20/2022
• Supplement Dates FDA Received: 07/22/2022; 09/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1