MAUDE Adverse Event Report: COVIDIEN UNKNOWN NEONATAL; UMBILICAL VESSEL CATHETER

Model Number UNKNOWN NEONATAL

Device Problem Material Fragmentation (1261)

Patient Problem Foreign Body Reaction (1868)

Event Type  Injury  

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with an umbilical vessel catheter (uvc).The customer reports a 3.5 dual lumen umbilical vessel catheter (uvc) was placed emergently in the main or following delivery of a 0.415 gram infant via emergency caesarian section.The flushed 3.5 fr double lumen catheter was advanced to 7 cm without difficulty.The line flushed and drew back easily, a 3.0 silk suture was not available in the or room at the time; however, a 3.0 coated suture was available.The catheter was sutured in place at 7cm with the 3.0 coated suture.After transferring the infant to the nicu an x-ray was taken of the line placement and showed the uvc needed to be adjusted back 1.5 cm.While the bedside nurse was pulling the uvc back to the correct position, the catheter snapped at the 6cm mark.The nurse was unable to grab the proximal tip and the catheter sunk deeper into the umbilical stump, 6cm of catheter remained in the umbilical vein and was not able to be retrieved.The patient was transferred to a specialty hospital for surgical removal of the catheter.

• Brand Name: UNKNOWN NEONATAL
• Type of Device: UMBILICAL VESSEL CATHETER
• Manufacturer (Section D): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer (Section G): COVIDIEN; covidien manufacturing solutions sa; edificio 820 calle #2 zona france coyol; alajuela ; CS
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5975428
• MDR Text Key: 55567257
• Report Number: 3009211636-2016-00410
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN NEONATAL
• Device Catalogue Number: UNKNOWN NEONATAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 09/23/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization