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U.S. Department of Health and Human Services


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Model Number 382544
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/07/2021
Event Type  malfunction  
Manufacturer Narrative
Medical device brand name: bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 18ga 1. 16in (1. 3 x 30 mm). Investigation summary: our quality engineer inspected the photograph submitted for evaluation. Bd received one photo in black and white color. Visual inspection of the photo found that needle can be seen piercing the catheter tubing. The defect of needle through catheter was confirmed. Additionally there was black coloring on the distal end of the catheter and inside the needle tip, indicating that media was present on the device. Since the unit had been used and media was observed inside the unit, it is unlikely that the defect occurred during manufacturing as the device would have been received with the needle piercing through the catheter tubing, making a venipuncture attempt unlikely. A needle spear through may occur in the user setting during tip adhesion break, during venipuncture if the needle is advanced at a wrong angle, or if the needle is moved up and down the catheter tubing. 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 Description
It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter blood control technology 18ga 1. 16in (1. 3 x 30 mm) had a needle through the catheter. The following information was provided by the initial reporter: "it was reported the plastic split away from the needle, no flashback".
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Brand NameSEE H.10.
MDR Report Key12703002
MDR Text Key278540793
Report Number1710034-2021-00918
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 10/06/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/27/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382544
Device Catalogue Number382544
Device Lot Number0324417
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/19/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial