MAUDE Adverse Event Report: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER; INTRAVASCULAR CATHETER

Model Number	382637
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of birth: only the patient's age was provided therefore a default date of birth has been listed.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 that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: used an iv cath on her, initially got good blood return, placement verified by us but the it felt as there was air coming into the cath or a leak.Attemped to make sure all connections were secure, no change.Had to pull this iv and establish another one.Felt this was faulty catheter.Difficult to assess if there was a hole in the catheter as there was blood in the cath.
Additional Manufacturer Narrative
H6: investigation summary since no samples displaying the condition reported were available for examination, we were unable to fully investigate this incident.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.
Event or Problem Description
It was reported that the bd insyte¿ autoguard¿ bc shielded iv catheter experienced leakage.The following information was provided by the initial reporter: used an iv cath on her, initially got good blood return, placement verified by us but the it felt as there was air coming into the cath or a leak.Attemped to make sure all connections were secure, no change.Had to pull this iv and establish another one.Felt this was faulty catheter.Difficult to assess if there was a hole in the catheter as there was blood in the cath.

• Brand Name: BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• MDR Report Key: 12310795
• Report Number: 1710034-2021-00697
• Device Sequence Number: 3817819
• Product Code: FOZ
• UDI-Device Identifier: 30382903826378
• UDI-Public: 30382903826378
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K110443
• 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): 09/02/2021

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: 10/31/2022
• Device Model Number: 382637
• Device Catalogue Number: 382637
• Device Lot Number: 9305409
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/14/2021
• Supplement Date Received by Manufacturer: 09/02/2021
• Initial Report FDA Received Date: 08/11/2021
• Supplement Report FDA Received Date: 09/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2019
• 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
• Patient Age: 68 YR