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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW MAC TWO-LUMEN/PSI KIT: 9 FR X 11.5 CM CATHETER,INTRAVASCULAR,THERAP

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ARROW INTERNATIONAL INC. ARROW MAC TWO-LUMEN/PSI KIT: 9 FR X 11.5 CM CATHETER,INTRAVASCULAR,THERAP Back to Search Results
Catalog Number ASK-11242-KSF
Device Problem Defective Component (2292)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/31/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Preliminary evaluation of the returned device indicates dilator tip damaged found during use.
 
Event Description
The customer reports that the tip of the dilator was frailed.
 
Event Description
The customer reports that the tip of the dilator was frailed.
 
Manufacturer Narrative
(b)(4). The customer returned one, assembled, two-lumen central venous access catheter and a lidstock for evaluation. Visual examination of the dilator revealed that the tip was damaged. The dilator tip showed signs of use in the form of dried blood. Microscopic examination revealed that the dilator was split in one location around the circumference of the tip. The circumference of the tip was slightly flared outward and white discoloration was found along the split , indicating stress. The dilator length from the distal end of the hub to the dilator tip measured 8 13/16", which matches the specification of 8 12/16"-8 14/16", per dilator product drawing. The dilator inner and outer diameter were also within specification. A device history record review was performed and no relevant findings were found to suggest a manufacturing issue. The ifu provided with the kit was also reviewed as part of this complaint investigation. It instructs the user to "enlarge cutaneous puncture site with cutting edge of scalpel positioned away from the spring-wire guide" prior to dilator insertion. The reported complaint that the dilator tip was damaged during use was confirmed through complaint investigation. The tip of the dilator was cracked with discoloration around the edges, indicating that it had undergone stress. A device history record review was performed and no relevant findings were found to suggest a manufacturing issue. Based on the condition of the returned sample and the customer report , it was determined that unintentional user error caused or contributed to this event. Teleflex will continue to monitor and trend for complaints of this nature.
 
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Brand NameARROW MAC TWO-LUMEN/PSI KIT: 9 FR X 11.5 CM
Type of DeviceCATHETER,INTRAVASCULAR,THERAP
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8080913
MDR Text Key127551836
Report Number1036844-2018-00296
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K002507
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 11/16/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/16/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date04/30/2019
Device Catalogue NumberASK-11242-KSF
Device Lot Number23F18B0188
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/06/2018
Is This a Reprocessed and Reused Single-Use Device? No

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