MAUDE Adverse Event Report: VYGON GMBH PREMICATH 28G 20CM CATHETER AND SPLITTING NEEDLE; LONG-TERM INTRAVASCULAR CATHETER

Model Number 1261.20G

Device Problems Fracture (1260); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/29/2019

Event Type  malfunction  

Manufacturer Narrative

The failed sample has been returned to vygon for device 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.

Event Description

While using a premicath 28g 20cm catheter, cracking was found near the hub when removing the dressing.It was removed from the patient, with no effect on patient.

Manufacturer Narrative

The complaint was forwarded to our parent company in germany for their evaluation.The investigation summary is as follows: we received the proximal part of the catheter which snapped just at the junction of the catheter and extension line.The part of the tube that detached was not returned.Microscopic examination of the breakage area showed the typical rough and jagged surface for a tensile breakage.From previous complaints we know different causes of tensile fracture can be: dressing change- in some instances the catheter can become adhered to the dressing and additional pulling is required to free it, placing stress on the line which results in a fracture.Routine care- such as when lifting the baby to change bedding, movement, the baby themselves catching the line (normally with a foot) disinfectants- it is essential to let disinfectants dry completely before the catheter is placed, as alcohol or organic solvents can damage the catheter material.Having checked batch history records, no abnormalities were found during the manufacturing run.Each catheter is flow and leak tested during production and the tensile force of the catheter component is randomly checked.Visual tests and incoming goods inspections are carried out.The tensile force of the catheter and extension line for the involved batch was between 3.33n and 5.51n and therefore within specification (1.5n).This is the second complaint for batch number 8023304 and the second complaint regarding a snapped catheter on code (b)(4).No further corrective action will be initiated by quality management at this time as manufacturing fault cannot be concluded.As the catheter worked well for 3 weeks, we do not believe this was caused by manufacturing.Vygon will continue to monitor for this issue.

Event Description

While using a premicath 28g 20cm catheter, cracking was found near the hub when removing the dressing.It was removed from the patient, with no effect on patient.

• Brand Name: PREMICATH 28G 20CM CATHETER AND SPLITTING NEEDLE
• Type of Device: LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): VYGON GMBH; prager ring 100; aachen, 52070 ; GM 52070
• MDR Report Key: 8679113
• MDR Text Key: 147342714
• Report Number: 2245270-2019-00032
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K954302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/09/2019

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 Model Number: 1261.20G
• Device Catalogue Number: 1261.20G
• Device Lot Number: 18J024D
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2019
• Initial Date Manufacturer Received: 05/31/2019
• Initial Date FDA Received: 06/07/2019
• Supplement Dates Manufacturer Received: 05/31/2019
• Supplement Dates FDA Received: 07/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1