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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381433
Device Problems Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)
Patient Problem Vessel Or Plaque, Device Embedded In (1204)
Event Date 06/22/2017
Event Type  Injury  
Manufacturer Narrative
Investigation: received one used 20g insyte autoguard iv catheter unit without packaging. The unit consisted of the catheter/adapter assembly with only a small portion of the catheter tubing protruding beyond the nose of the adapter. A miscellaneous ex-tube was attached at the end of the adapter. The ex-tube was looped and there were tape strips and a transparent dressing adhered to the ex-tube and the adapter portion of the used unit (catheter/adapter assy. ) there were traces of dried media present on the unit. The unit was attached to a miscellaneous extension line w/and miscellaneous injection site. Visual/microscopic evaluation revealed the area of separation at the catheter tubing had jagged and rough edges with indication of stress. Measurement revealed; there was approximately 0. 305¿ tubing protruding from the nose of the adapter to the highest point of the tubing. A review of the device history record could not be performed as a lot number was not provided for this incident. Confirmation of the defect of catheter broke, as stated in the product incident report, was conclusive based on the evaluation of the unit provided for this incident. Confirmed the catheter tubing had been separated (broken) by excessive stress resulting in rough, jagged edges. The tubing was at approximately 0. 305¿ from the nose of the adapter to the highest point in the tubing at the area of separation. There was no physical evidence to confirm or to support manufacturing process related issues for the defect stated in the pir. This incident is indeterminate. Confirmation of the customer¿s experience with the bd product was conclusive based on the review of the returned unit. The root cause was determined to be separation by stress in the clinical setting; the rough jagged edges and stress to the area of separation were indicative of excessive stress to the.
 
Manufacturer Narrative
Medical device expiration date: unknown. No lot # provided. A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. The initial reporter also notified the fda on 07/17/2017 via medwatch (b)(4). Device manufacture date: unknown (b)(4).
 
Event Description
It was reported that as the patient moved in bed, the hub of the 20 g x 1. 00 in. Bd insyte¿ autoguard¿ shielded iv catheter dislodged leaving part of the catheter in the patient¿s vein. Patient was sent to vascular surgery where 1. 8cm of the catheter was retrieved from the patient¿s right antecubital subcutaneous tissue.
 
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Brand Name20 G X 1.00 IN. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER
Type of DeviceINTRAVASCULAR 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
brett wilko
9450 south state street
sandy, UT 84070
8015652845
MDR Report Key6817894
MDR Text Key249071476
Report Number1710034-2017-00144
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/12/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number381433
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/31/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/24/2017 Patient Sequence Number: 1
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