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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CVC KIT: 3-LUMEN 8,5FR X 16CM; ADULT MULTI LUMEN CATHETER PRODUCTS
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ARROW INTERNATIONAL INC. CVC KIT: 3-LUMEN 8,5FR X 16CM; ADULT MULTI LUMEN CATHETER PRODUCTS Back to Search Results
Catalog Number NL-12853-MUMC
Device Problems Difficult or Delayed Positioning (1157); Difficult or Delayed Activation (2577)
Patient Problems Abrasion (1689); Injury (2348)
Event Date 06/01/2016
Event Type  Injury  
Manufacturer Narrative
(b)(4).No sample will be returned for evaluation.
 
Event Description
It was reported that the user met with difficulty when opening the scalpel.Force was then used resulting in the user cutting his hand requiring stitches.There was no reported delay, death, or complications to the patient as a result of this occurrence.
 
Manufacturer Narrative
(b)(4).No sample will be returned for evaluation.Additional information: this product is not sold in the us.The 510k number provided is for a similar product that is sold in the us.
 
Event Description
It was reported that the user met with difficulty when opening the scalpel.Force was then used resulting in the user cutting his hand requiring stitches.There was no reported delay, death, or complications to the patient as a result of this occurrence.
 
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Brand Name
CVC KIT: 3-LUMEN 8,5FR X 16CM
Type of Device
ADULT MULTI LUMEN CATHETER PRODUCTS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ   591 01
Manufacturer Contact
jamie hartz
2400 bernville road
reading, PA 19605
MDR Report Key5710384
MDR Text Key47087872
Report Number3006425876-2016-00171
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 06/02/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/30/2018
Device Catalogue NumberNL-12853-MUMC
Device Lot Number71F15M0449
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Date Manufacturer Received06/02/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/08/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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