MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM); INTRAVASCULAR CATHETER

Model Number	381534
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported bd insyte¿ autoguard¿ winged shielded iv catheter 20ga 1.16in (1.1 x 30 mm) had leakage issues.The following information was provided by the initial reporter: "iv placed , when i attempted to flush leaking at connection between angiocath and extension tubing.".
Event or Problem Description
It was reported bd insyte¿ autoguard¿ winged shielded iv catheter 20ga 1.16in (1.1 x 30 mm) had leakage issues.The following information was provided by the initial reporter: "iv placed , when i attempted to flush leaking at connection between angiocath and extension tubing.".
Additional Manufacturer Narrative
H6: investigation summary: our quality engineer inspected the samples submitted for evaluation.Bd received two catheter adapter assemblies, a miscellaneous extension line with a luer lock connection at one end, and a miscellaneous injection site at the opposite end.Upon inspection of the catheter adapter assemblies, it was found that the outer thread at the end of the luer adapter was smashed.The reported defect was confirmed.This type of damage to the adapter would most likely prevent a successful connection which would lead to leakage.Leakage was observed during the water/ air leak test, confirming an inadequate connection.Based on the appearance of the damage, the defect most likely occurred due to misalignment during manufacturing.Preventative maintenance and sampling is performed at regular intervals to mitigate the risk from this type of defect.A device history record review showed no non-conformances associated with this issue during the production of this batch.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ WINGED SHIELDED IV CATHETER 20GA 1.16IN (1.1 X 30 MM)
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12393143
• Report Number: 1710034-2021-00770
• Device Sequence Number: 4648590
• Product Code: FOZ
• UDI-Device Identifier: 30382903815341
• UDI-Public: 30382903815341
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K201075
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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
• Operator of Device: Other
• Device Expiration Date: 02/29/2024
• Device Model Number: 381534
• Device Catalogue Number: 381534
• Device Lot Number: 1078998
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2021
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 09/14/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1