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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL, INC, SUBSIDIARY OF TELEFLEX, INC. ARROW MIDLINE MIDLINE CATHETER

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ARROW INTERNATIONAL, INC, SUBSIDIARY OF TELEFLEX, INC. ARROW MIDLINE MIDLINE CATHETER Back to Search Results
Lot Number 23F19M0042
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 03/25/2020
Event Type  Injury  
Event Description
Glide thru peel away sheath broke at neck while peeling away causing it to slip beneath the skin. Unable to retrieve. Fda safety report id# (b)(4).
 
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Brand NameARROW MIDLINE
Type of DeviceMIDLINE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL, INC, SUBSIDIARY OF TELEFLEX, INC.
MDR Report Key9994988
MDR Text Key188985295
Report NumberMW5094242
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date03/31/2021
Device Lot Number23F19M0042
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Was Device Evaluated by Manufacturer?
Is the Device Single Use?
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

Patient Treatment Data
Date Received: 04/23/2020 Patient Sequence Number: 1
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