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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM CATHETER, INTRAVASCULAR, THERAPEUTIC

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ARROW INTERNATIONAL INC. ARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM CATHETER, INTRAVASCULAR, THERAPEUTIC Back to Search Results
Catalog Number CDC-41541-MPK1A
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Lot# unknown. Potential lot# 23f18h0726.
 
Event Description
The customer reports that the user attempted to peel apart the peel way introducer and it wouldn't peel apart approximately 1 cm from the tip to the end of the sheath.
 
Manufacturer Narrative
(b)(4). The customer did not return a complaint sample; however, they supplied a photo showing the defective peel-away sheath. Both peel-away sheath tabs appear to have broken off and signs of use is evident. The catheter was included in the image; however, the separated tabs were not included in the photo. A probable cause of the damaged peel-away sheath cannot be determined from the photo and without a sample to evaluate. A device history record review was performed with no relevant findings to suggest a manufacturing issue. The ifu provided with the kit warns the user to "avoid tearing sheath at insertion site which opens surrounding tissue creating a gap between catheter and dermis. " the report that the peel-away sheath tabs broke off in use was confirmed through examination of the customer supplied photo. The image showed that both peel-away sheath tabs had broken off; however, the actual complaint sample was not returned for evaluation. The device history record review revealed no evidence to suggest a manufacturing related cause. The probable cause of the peel-away sheath damage could not be determined based upon the information provided and without an actual complaint sample to evaluate. Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports that the user attempted to peel apart the peel way introducer and it wouldn't peel apart approximately 1 cm from the tip to the end of the sheath.
 
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Brand NameARROW AM/AT PI MIDLINE 1-L: 4.5FR X 15CM
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8115276
MDR Text Key128758535
Report Number1036844-2018-00289
Device Sequence Number1
Product Code FOZ
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 11/12/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/29/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCDC-41541-MPK1A
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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