MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC UV CATHETER

Model Number 8888160333 3.5FR P.U.R. UMBILCA

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/18/2017

Event Type  malfunction  

Event Description

Two occurrences, same product (b)(6) 2017: product for premie baby in nicu: (b)(6) 2017: uv catheter leaking at distal attachment to inbuilt luer adaptor; and (b)(6) 2017: uac tore at the connection of the leur lock.Product returned to mfg for evaluation, response received from manufacturer.Analysis: the complaint was investigated.Sample consisted in 2 used uvc catheter and 2 packages closed.The sample came inside a generic plastic bag.During visual inspection, the used catheters revealed that the samples were manipulated: due to the samples presented remains of blood.Under water test was performed and a leak below the strain relief could be identified in the catheters, however the origin of the leak could not be observed with a naked eye.Magnified pictures were taken and hole below the strain relief was observed.In order to confirm the reported defect, the packages closed were opened and were submitted to under water test and as a result it did not show any leakage or issue.In the evaluation sample were found the lot numbers: 163210144 and 1632100151.An (b)(4) diagram was used to determine the potential causes for this event, this is a potential failure mode if the following possible causes are present: through sample evaluation it was observed that two of the catheters that return presented a hole below the strain relief, the uvc catheter showed signs of being used in a patient, the other catheters do not present any defect during the test.It must be noted that in-process controls (such as personnel training, incoming quality acceptance testing for raw material, 100 percent in process visual inspection and visual acceptance sampling) are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.No patient harm as a result of this product problem.

• Brand Name: MEDTRONIC UV CATHETER
• Type of Device: MEDTRONIC UV CATHETER
• Manufacturer (Section D): MEDTRONIC; mansfield
• MDR Report Key: 6618378
• MDR Text Key: 77002907
• Report Number: MW5070199
• Device Sequence Number: 1
• Product Code: FOS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 06/02/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8888160333 3.5FR P.U.R. UMBILCA
• Device Lot Number: 16321000144
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 2 DA