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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW CVC KIT: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS Back to Search Results
Model Number IPN037334
Device Problems Crack (1135); Gas/Air Leak (2946)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/25/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
Customer reported that the jugular was punctured according to specification.During the puncture, air was drawn and not blood aspirated as expected.After examination, it was observed that the cone of the needle had cracks.It is known that the patient was not harmed , and there was no influence on the therapy.
 
Event Description
Customer reported that the jugular was punctured according to specification.During the puncture, air was drawn and not blood aspirated as expected.After examination, it was observed that the cone of the needle had cracks.It is known that the patient was not harmed , and there was no influence on the therapy.
 
Manufacturer Narrative
(b)(4).The customer returned one introducer needle for analysis.Signs-of-use in the form of biological material was observed on the needle cannula.Visual examination of the introducer needle revealed that the hub was cracked.Microscopic examination confirmed the crack.Additionally, the needle cannula appeared to be fully recessed inside the needle hub.The returned needle was attached to a lab inventory ars and water was aspirated and purged.A significant amount of water and air leakage was detected from the crack in the needle hub.A device history record review was performed with no relevant findings identified.The reported complaint that the introducer needle hub was cracked was confirmed through complaint investigation.The returned introducer needle contained a single crack in the hub.A device history record review was performed, and no relevant manufacturing issues were identified.Further investigation of this issue is being conducted under a capa.The capa failure investigation indicates that the probable cause is design related.Teleflex will continue to monitor and trend for reports of this nature.
 
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Brand Name
ARROW CVC KIT: 3-LUMEN 7FR X 20CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10122986
MDR Text Key194627901
Report Number3006425876-2020-00496
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 05/25/2020
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 Date01/31/2024
Device Model NumberIPN037334
Device Catalogue NumberDE-15703-KKSI
Device Lot Number71F20B2788
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/04/2020
Initial Date Manufacturer Received 05/25/2020
Initial Date FDA Received06/05/2020
Supplement Dates Manufacturer Received07/01/2020
Supplement Dates FDA Received07/01/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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