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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW ANESTHESIA CONDUCTION KIT

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ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ARROW ANESTHESIA CONDUCTION KIT Back to Search Results
Model Number IPN047003
Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/19/2018
Event Type  malfunction  
Event Description
During epidural catheter insertion, catheter was inserted into wrong area and upon removal, it sheared and a tip was left inside the patient's soft tissue. The patient will be given the option to have the tip surgically removed.
 
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Brand NameARROW
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.)
2400 bernville road
reading PA 19605
MDR Report Key7457960
MDR Text Key106449281
Report Number7457960
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/31/2019
Device Model NumberIPN047003
Device Catalogue NumberASK-05500-MCV1
Device Lot Number23F17K0132
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/20/2018
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer04/20/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 04/25/2018 Patient Sequence Number: 1
Treatment
NO
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