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U.S. Department of Health and Human Services

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

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Model Number 382512
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/17/2021
Event Type  malfunction  
Manufacturer Narrative
Investigation summary: two photos were received by our quality team for evaluation. From the photos, the top web of a unit package and a view of the catheter adapter assembly with a foreign matter extending from the catheter tubing was observed. Visual observation reveals that the foreign matter on the tubing is hair, confirming the reported nonconformance. A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found. It is possible for human hair to get into the packaging during any point humans are in the same room as the material. The hair could come with the packaging raw material and be trapped inside of the top or bottom webbing role. The hair could also be introduced during packaging or manufacturing by accident or due to improper gowning. After investigation, no evidence to suggest that either gowning or inspection procedures were not followed. This scenario is likely. 5s cleaning is performed by each shift to minimize the potential for introducing foreign matter to the product. The quality control plan, visual inspection, environmental monitoring, and gowning procedure are followed. The potential for the introduction of foreign matter does present itself in the clinical setting. As seen in the photo, the unit was opened, removed from the package, and manipulated. Therefore, the user practice cannot be ruled out as a possibility for the introduction of foreign matter. The origin of the foreign matter, introduction during manufacturing or user are both potentials. This incident has been added to our database of reported incidents.
 
Event Description
It was reported when using the bd insyte¿ autoguard¿ bc shielded iv catheter, the device experienced foreign matter in the device catheter. The following information was provided by the initial reporter. The customer stated:   wanted to let you know that i pulled a needle out of sterile packaging today, it was capped and appeared normal until i took off the cap and there was a black hair on the end of the needle. The hair is on the catheter.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ BC SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
9450 south state street
sandy UT 84070
MDR Report Key12665088
MDR Text Key277398231
Report Number1710034-2021-00896
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier30382903825128
UDI-Public30382903825128
Combination Product (y/n)N
PMA/PMN Number
K110443
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial
Report Date 09/29/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number382512
Device Catalogue Number382512
Device Lot Number1090022
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/21/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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