MAUDE Adverse Event Report: COVIDIEN 3.5/5.0FR PU UVC TRAY; CATHETER, UMBILICAL ARTERY

Model Number 8888160119

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/20/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports they found the uvc line cracked.The pa was called immediately to bedside and discontinued the line.Line collected and held at bedside.Fluid/medication connected to existing peripheral line.Upon follow up on (b)(6) 2019, the customer stated that the crack was noticed on the end of the line.The device was still whole (did not separate into two pieces).Patient information is not available.There was no difficulty prepping device.Packaging has been discarded.It is not known if there was any the anomaly noted prior to inserting into the patient.It is not known if there was any damage to the device noticed prior to opening the package or difficulty removing the device from the sterile packaging.There were no kinks or damages prior to insertion into patient.

Manufacturer Narrative

No lot number was provided.However, all dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Manufacturing performs 100% leak testing for this product, which would identify this issue in the catheter assembly.No product/sample was provided for evaluation.Customer indicated they were unable to locate the product/sample.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.

• Brand Name: 3.5/5.0FR PU UVC TRAY
• Type of Device: CATHETER, UMBILICAL ARTERY
• Manufacturer (Section D): COVIDIEN; edificio b20 calle #2 zona fra; alajuela ; CS
• MDR Report Key: 8418044
• MDR Text Key: 138791831
• Report Number: 3009211636-2019-00647
• Device Sequence Number: 1
• Product Code: FOS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 04/26/2019

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: No Information
• Device Model Number: 8888160119
• Device Catalogue Number: 8888160119
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/08/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 03/08/2019
• Supplement Dates FDA Received: 04/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1