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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¿ 22G X 1.0 IN INTRAVASCULAR CATHETER

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BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. BD INSYTE¿ AUTOGUARD¿ 22G X 1.0 IN INTRAVASCULAR CATHETER Back to Search Results
Catalog Number 381823
Device Problems Break (1069); Component Missing (2306)
Patient Problems Cellulitis (1768); Pain (1994); Swelling (2091)
Event Date 01/15/2017
Event Type  Injury  
Manufacturer Narrative
(b)(4). The medical device expiration date is unknown as the lot number is unknown. (b)(6). The device manufacture date is unknown as the lot number is unknown. Device evaluation: result - bd received one used 22g iag catheter unit without packaging. The unit consisted of the adapter with a very small portion of catheter tubing protruding beyond the nose of the adapter. The unit had a dual injection line attached to the end of the adapter. There was a transparent dressing wrapped around the adapter. There were traces of dried media. The remainder of the unit was not returned for evaluation. A visual examination was performed. The tubing measured approximately 0. 0287¿ from the nose of the adapter to the area of separation. The area of separation was on an angle and revealed the characteristics of a smooth cut (edges) to the tubing. There were no scratches or scuff markings to any area of the catheter tubing wall. A review of the device history record cannot be completed as the lot number was not provided for this incident. Conclusion - a definite root cause could not be established. The cut with smooth edges and at the catheter tubing are evidence of misuse. It is uncertain whether the defects experienced by the customer were contributed to by manipulation of the device prior to insertion or by the manufacturing process. Where the defect occurred (clinical environment or manufacturing) is indeterminate.
 
Event Description
It was reported that the patient was admitted to sw2 (surgical unit) on (b)(6) 2017 for cellulitis to the right hand and removal of cannula that was retained in her arm 7 years ago. The suspect device was placed by an anesthetist to the patient's left ankle (at a point of flexion) midday on the day of admission. The insertion was noted to be successful upon first attempt, reporting the catheter/stylet was not withdrawn at any time during the procedure. On (b)(6) 2017, the patient rang her bell and requested to have her infusion reconnected to her iv. The nurse flushed the suspect device with normal saline 5ml and the patient complained of pain. The flush was stopped and the site was checked by removing the bandage. Leakage was noted and when the nurse removed the tegaderm dressing to remove the device, the tip of the cannula was missing. At 0740, after patient handover was finished, the nurse who initially discovered the missing cannula called an additional nurse to assess the iv site. This nurse noted the tegaderm had been pulled halfway from the site and noted the "front part of the loop missing and not visible, only the end part and the claves (sp)" could been seen. The site was palpated, which proved very painful and minimal swelling was noted to the ankle area. The nurse did not feel anything under the skin upon palpation and no bleeding was noted. The doctor was notified and x-rays were ordered. Results of a left limb ultrasound showed hyperechoic cannulated structure to the medial ankle in the subcutaneous soft tissue. The patient reported severe pain over the next 12 hours and was given dicloflame, tramacet, and tramal for the pain. Surgery was performed to remove the broken catheter.
 
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Brand NameBD INSYTE¿ AUTOGUARD¿ 22G X 1.0 IN
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 Key6344409
MDR Text Key67819985
Report Number1710034-2017-00040
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSF
PMA/PMN Number
K952861
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation
Type of Report Initial
Report Date 02/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/20/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number381823
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/30/2017
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

Patient Treatment Data
Date Received: 02/20/2017 Patient Sequence Number: 1
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