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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC SET: 14 GA X 6" (16 CM); CATHETER PERCUTANEOUS Back to Search Results
Catalog Number CS-24706-E
Device Problems Break (1069); Material Separation (1562)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/04/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The customer reports: the puncture position was inserted into the subclavian vein.When the needle entered the patient's body.The steel needle and the steel needle connecting seat are broken, retract the needle, and use a new set of products.
 
Event Description
The customer reports: the puncture position was inserted into the subclavian vein.When the needle entered the patient's body.The steel needle and the steel needle connecting seat are broken, retract the needle, and use a new set of products.
 
Manufacturer Narrative
(b)(4).The actual sample was not returned; however, the customer provided a photo for evaluation.Visual inspection of the photo revealed two 18 ga introducer needles with their cannulas severely bent to the point of almost separating.A complete visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed, and one relevant finding was found for the introducer needle.A non-conformance was initiated to address the issue of the needle becoming undocked from the hub during puncture.It cannot be determined if this damage is related to the complaint without the sample returned.The instructions for use (ifu) provided with this kit instructs the user, "insert introducer needle with attached arrow raulerson syringe into vein and aspirate." the complaint of a broken needle cannula was confirmed by the customer's photo.Visual inspection of the photo revealed two introducer needles with their cannulas bent almost to the point of separation.A device history record review was performed, and one relevant finding was found for the introducer needle.It cannot be determined if this damage is related to the complaint without the sample returned.Without the device to evaluate, 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 CVC SET: 14 GA X 6" (16 CM)
Type of Device
CATHETER PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10437367
MDR Text Key203862901
Report Number3006425876-2020-00768
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K862056
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/11/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Expiration Date03/24/2021
Device Catalogue NumberCS-24706-E
Device Lot Number71F19E0993
Was Device Available for Evaluation? No
Date Manufacturer Received09/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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