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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYGON USA PREMICATH; LONG-TERM INTRAVASCULAR CATHETER
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VYGON USA PREMICATH; LONG-TERM INTRAVASCULAR CATHETER Back to Search Results
Model Number 1261.203G
Device Problems Unintended Movement (3026); Migration (4003)
Patient Problems Inflammation (1932); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/21/2023
Event Type  malfunction  
Manufacturer Narrative
The device will be returned to vygon for evaluation as part of the complaint investigation.The results of this investigation are still pending, and will be communicated to fda within 30 days of its conclusion via follow-up mdr.
 
Event Description
Infiltration into baby's svc.
 
Manufacturer Narrative
The sample is still in decontamination process and has not been returned for evaluation.The results of this investigation is still pending.
 
Event Description
Infiltration into baby's svc.No pump alarm.No indication that something was wrong with the picc.The infiltration was found after contrast was injected into picc and infant's neck was noted to be swollen bilaterally.
 
Manufacturer Narrative
The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: the customer returned a 30 cm long premicath catheter instead of 20 cm length code 1261.203g.The used sample arrived in three fragments: the first fragment had a length of 18.5 cm.The fractured plane at its proximal end was rough and uneven.The second fragment had a length of 1 cm with the 19 cm marking in its middle proximal end.Both ends of this fragment have a rough and uneven fractured plane.The last fragment from 19.5 cm to its proximal end including the extension line also showed a rough and uneven distal fracture plane.A review of the batch history records was performed for batch no.8131568, 8134057, and 8138681, and no deviations were found.The batches complied with their specifications and were released.Each catheter is flow and leak tested during production.The tensile force of the catheter components is randomly checked.Visual tests and incoming goods inspections are carried out with no exceptions found.No similar complaints regarding a swollen neck after contrast injection were ever received on code 4g07126103.Corrective action: as the catheter worked well for 10 days before the swollen neck after contrast injection occurred, we do not believe this defect was manufacturing related.Any manufacturing problems that would lead to a leak/rupture would be detected by the user when flushing the catheter.Additionally, the product incident report mentioned that there was no indication that something is wrong with the picc.Therefore, no further corrective action will be initiated at this time.
 
Event Description
Infiltration into baby's svc.No pump alarm.No indication that something was wrong with the picc.The infiltration was found after contrast was injected into picc and infant's neck was noted to be swollen bilaterally.
 
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Brand Name
PREMICATH
Type of Device
LONG-TERM INTRAVASCULAR CATHETER
Manufacturer (Section D)
VYGON USA
2750 morris road
lansdale PA 19446
Manufacturer (Section G)
VYGON MFG
87 venture drive
dover NH 03820 3816
Manufacturer Contact
freda lacroix
2750 morris road
lansdale, PA 19446
8004735414
MDR Report Key16361647
MDR Text Key309371043
Report Number2245270-2023-00008
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K041468
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/05/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/13/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number1261.203G
Device Lot Number21D015D
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received02/03/2023
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Age42 DA
Patient SexFemale
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