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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE; MIDLINE CATHETER
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ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE; MIDLINE CATHETER Back to Search Results
Catalog Number VASCULAR UNKNOWN
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
Manufacturer Narrative
Qn# (b)(4).
 
Event Description
Customer reported "the pa was having trouble placing the midline in the sheath.She said it felt tight.She had to put the wire back into the catheter to push it through the sheath.She also said when she peeled the sheath, the sheath pieces were ridged (not smooth)." issue was detected over the span of a couple weeks, exact number of times was unknown.It was reported "each patient was fine they just had to drop another sheath and dilator on the field".
 
Event Description
Customer reported "the pa was having trouble placing the midline in the sheath.She said it felt tight.She had to put the wire back into the catheter to push it through the sheath.She also said when she peeled the sheath, the sheath pieces were ridged (not smooth)." issue was detected over the span of a couple weeks, exact number of times was unknown.It was reported "each patient was fine they just had to drop another sheath and dilator on the field".
 
Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW AM/AT PI MIDLINE
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12029952
MDR Text Key257266173
Report Number9680794-2021-00303
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberVASCULAR UNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received07/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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