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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS
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ARROW INTERNATIONAL INC. ARROW ARTERIAL CATH SET: 20GA X 8CM; CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number SAC-00820
Device Problems Device Damaged Prior to Use (2284); Material Twisted/Bent (2981)
Patient Problem No Patient Involvement (2645)
Event Date 12/26/2019
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).
 
Event Description
The customer reports: the catheter has a double in the guide, the outer packaging does not have doubles to say that it is folded at the time of handling, the outer packaging is intact without signs of doubling.The customer confirms that the guide is bent.
 
Manufacturer Narrative
(b)(4).The customer returned one unopened sac set with a straight guide wire and a single-lumen arterial catheter for analysis.Visual analysis revealed that the guide wire contained one distinct kink.The arterial catheter was opened and microscopic examination revealed a white stress mark on the tubing at the same location as the kink on the guide wire when fully inserted.The damage observed is consistent with defects related to shipping and handling of other sac sets.No other defects or anomalies were observed.The kink in the guide wire measured 259mm from the proximal tip.The guide wire length measured 350mm, which is within the specification limits of 345mm-355mm per the guide wire product drawing.The guide wire outer diameter measured 0.521mm, which is within the specification limits of 0.508mm-0.533mm per the guide wire product drawing.A device history record review was completed with no relevant findings.The lidstock was reviewed as part of this complaint investigation.The words "do not bend" are clearly visible on the front of the lidstock.An engineering change order was implemented in april 2017 to update the product labeling to clearly inform the customer to not bend the product and is intended to reduce the potential for product damage.The reported complaint that the guide wire was found kinked prior to use was confirmed through both visual inspection of the returned sample.The returned guide wire contained one distinct kink.The guide wire tubing also contained a stress mark right over the location where the kink in the guide wire is located when fully inserted into the tubing.The words "do not bend" are clearly visible on the front of the lidstock, which is intended to heighten customer awareness and mitigate the risk of kinking the components during storage and shipping of this product.The guide wire met all relevant dimensional requirements, and a device history record review was performed with no relevant findings.Based on the customer description and the sample received, storage and shipping caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports: the catheter has a double in the guide, the outer packaging does not have doubles to say that it is folded at the time of handling, the outer packaging is intact without signs of doubling.The customer confirms that the guide is bent.
 
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Brand Name
ARROW ARTERIAL CATH SET: 20GA X 8CM
Type of Device
CATHETER, PERCUTANEOUS
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9577820
MDR Text Key180127411
Report Number3006425876-2020-00012
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
PMA/PMN Number
K093050
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberSAC-00820
Device Lot Number71F19H1267
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/31/2020
Date Manufacturer Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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