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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL
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ARROW INTERNATIONAL INC. ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM; CATHETER HEMODIALYSIS NON IMPL Back to Search Results
Catalog Number CU-22122-F
Device Problem Loose or Intermittent Connection (1371)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/13/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
The complaint is reported as: "md was performing the procedure according to ifu.Md found the needle hub and the lure-lock tip of the syringe loose and disconnected.So md judged it as a defective product and used new kit".It was reported there were two devices with this issue used on the same patient.No patient harm reported.The patient's condition is reported as fine.
 
Event Description
The complaint is reported as: "md was performing the procedure according to ifu.Md found the needle hub and the lure-lock tip of the syringe loose and disconnected.So md judged it as a defective product and used new kit".It was reported there were two devices with this issue used on the same patient.No patient harm reported.The patient's condition is reported as fine.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one ars, 18 ga introducer needle, and catheter/needle assembly for evaluation.Visual inspection did not reveal any defects or anomalies.There were no cracks observed in either needle hub.The ars tip appeared normal.Both the introducer needle and catheter/needle assembly were functionally tested with the returned ars per the instructions for use (ifu).The ifu states, "insert introducer needle with attached arrow raulerson syringe (where provided) into vein and aspirate.Catheter/needle may be used in the standard manner as alternative to introducer needle.If catheter/needle is used, arrow raulerson syringe will function as a standard syringe, but will not pass spring-wire guide." both returned needles felt secure on the ars and were able to draw and aspirate water with no issues.The hub of the introducer needle and catheter/needle assembly were tested with the male luer gage and were within the specified range.This indicates that the luers conforms to iso 594-1:1986.The tip of the ars was tested with the female luer gage and was within the specified range.This indicates that the ars tip conforms to iso 594-1:1986.A device history record review was performed, and no relevant findings were identified.The complaint of syringe/needle connection not secure was not able to be confirmed by a complaint investigation of the returned sample.Both returned needles and ars met all relevant functional testing.A device history record review was performed, and no relevant findings were identified.Based on the product returned, no problem was found on the sample.Teleflex will continue to monitor and trend on complaints of this nature.
 
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Brand Name
ARROW HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM
Type of Device
CATHETER HEMODIALYSIS NON IMPL
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key12260239
MDR Text Key264551042
Report Number3006425876-2021-00715
Device Sequence Number1
Product Code MPB
Combination Product (y/n)N
PMA/PMN Number
K993933
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Type of Report Initial,Followup
Report Date 07/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/28/2022
Device Catalogue NumberCU-22122-F
Device Lot Number71F20H3004
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/30/2021
Initial Date Manufacturer Received 07/16/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received08/18/2021
Supplement Dates FDA Received08/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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