MAUDE Adverse Event Report: COVIDIEN 3.5FR URETHANE UMB CATH; UMBILICAL VESSEL CATHETER

Model Number 8888160333

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

Submit date: 03/04/2016.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 representative reports that the line was primed with a syringe and 10% dextrose solution prior to insertion.No leak was evident during priming.Immediately after inserted and following x-ray confirmation of correct positioning, the line was hooked up to the dextrose infusion and a leak was noted from the hub around the catheter insertion point to the hub (when backflow of blood presented).The line was immediately removed and replaced.This fault required a second unnecessary x-ray for the infant, in order to confirm portion of the replacement line required.A crack was seen and felt on the plastic hub.Chlorhexidine was used to clean the skin area and the area was completely dried prior to insertion.The catheter was inserted as per manufacturer guidelines.The uvc was inserted on (b)(6) 2016 in the umbilicus.The uvc was in continuous use.The catheter tubing was not being cleaned.The uvc was removed (b)(6) 2016 and was replaced with a cvl.The patient is stable (no harm had befallen the patient).

Manufacturer Narrative

Submit date: 06/14/2016.This sample was included with multiple samples that were sent to the plant via (b)(6) and were mistakenly left off the tracking log and packing list therefore it cannot be located at the plant as they were not able identify the sample.The manufacturing lot number associated with this complaint was 1513200059.The device history record (dhr) review indicated that there was no quality issues associated with this reported condition.All dhr¿s are reviewed for accuracy prior to product release.Without the sample it is not possible to determine a root cause for this issue.No triggers or trend are found this event; no further actions are required for this investigation at this time.In general, in-process controls such as personnel training, incoming quality acceptance testing for raw material, in process visual inspection and visual acceptance sampling are in place to prevent nonconforming product from leaving the manufacturing operations.As per product specification, manufacturing performs 100% pressure testing during production, which would identify this issue in the catheter assembly.No further actions are required.This complaint will be used for tracking and trending purposes.

• Brand Name: 3.5FR URETHANE UMB CATH
• 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 solulfons sa; edificio 820 calle #2 zona franca coyol; alajuela 20101 ; CS 20101
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5482676
• MDR Text Key: 40029048
• Report Number: 3009211636-2016-00112
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Reporter Country Code: NZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333
• Device Catalogue Number: 8888160333
• Device Lot Number: 1513200059
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/14/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1