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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON USA 4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY; MIDLINE CATHETER
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VYGON USA 4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY; MIDLINE CATHETER Back to Search Results
Model Number VYML4S1001
Device Problems Device Misassembled During Manufacturing /Shipping (2912); Component Misassembled (4004)
Patient Problems Tissue Damage (2104); Blood Loss (2597)
Event Date 09/22/2019
Event Type  malfunction  
Manufacturer Narrative
The samples will be returned to vygon and the events will be evaluated as part of the complaint investigation.The results of this investigation are still pending and will be communicated to fda within 30 days of completion.Vygon has also initiated a recall of the affected product.Five occurences of this product problem were reported, the details of the other four can be found in: mdr 2245270-2019-00061; mdr 2245270-2019-00062; mdr 2245270-2019-00063; mdr 2245270-2019-00064.
 
Event Description
Customer reported that the vyml4s1001 trays contained 3 fr single midlines instead of 4 fr single midlines as labeled.The cno was notified once the problem was identified.Placement of the incorrect size midline resulted in bleeding and unnecessary vein trauma to the patient.
 
Event Description
Customer reported that the vyml4s1001 trays contained 3 fr single midlines instead of 4 fr single midlines as labeled.The cno was notified once the problem was identified.Placement of the incorrect size midline resulted in bleeding and unnecessary vein trauma to the patient.
 
Manufacturer Narrative
Five occurences of this product problem were reported, the details of the other four can be found in: mdr 2245270-2019-00061, mdr 2245270-2019-00062, mdr 2245270-2019-00063, and mdr 2245270-2019-00064.After conducting a thorough investigation, vygon can confirm a quality problem with this product.The cause was a manufacturing error where the product was mis-assembled.This issue occured during a warehouse picking process as some of the wrong catheters were selected for the work order.Based on a review of the remaining component inventory from the same lot, the components were labeled correctly so it can be concluded that this was a human error.This mistake was not caught during the production process.The product's lot history record was reviewed, and several other aspects were missed such as quality sample timing per the associated procedures.The root cause is a manufacturing issue resulting from a combination of human error, failure to follow procedure, and lack of adequate qms processes.This is the first complaint for this product code and issue; however, due to the issue reported and potential harm, a corrective and preventative action (capa) and recall were required.Corrective and preventative actions: vygon usa issued a voluntary recall due to this customer claim.Reference : capa - 00597, recall-2019-01.Update all production and quality work instructions to ensure that these are adequate to prevent re-occurence and are not conflicting.Reference : capa-00597.Implement a better process for sorting/tracking catheter inventory at vygon mfg to avoid picking mix-ups.Reference : capa-00597.
 
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Brand Name
4FR X 20CM SINGLE LUMEN CT MIDLINE BASIC TRAY
Type of Device
MIDLINE CATHETER
Manufacturer (Section D)
VYGON USA
2750 morris road
lansdale PA 19446
MDR Report Key9139818
MDR Text Key162014329
Report Number2245270-2019-00060
Device Sequence Number1
Product Code PND
Combination Product (y/n)N
PMA/PMN Number
K181208
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Remedial Action Recall
Type of Report Initial,Followup
Report Date 11/07/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/01/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberVYML4S1001
Device Catalogue NumberVYML4S1001
Device Lot Number19G020D
Was Device Available for Evaluation? Yes
Date Manufacturer Received09/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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