MAUDE Adverse Event Report: COVIDIEN PVC FEEDING TUBE 5 FR 16IN; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number	460802
Medical Device Problem Codes	Difficult to Remove (1528); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
The customer reported that the patient was scheduled for a vcug for bilateral hydronephrosis.A 5 fr feeding tube was used over label as a catheter.After it was placed, it was noted to be coiled in the bladder and they were unable to proceed with the procedure or remove the catheter.A urologist in lubbock was consulted who provided several suggestions on techniques that could be employed in attempting to remove the catheter.Various wires were passed through the catheter in an attempt to uncoil.The bladder was filled and the catheter was advanced back into the ladder and a stiffer guide-wire was passed through the catheter to help straighten the tube.Lidocaine jelly was used to relieve discomfort and relax the proximal sphincter.After approximately an hour the radiologist and rnp were able to successfully remove the catheter.The patient did not require further work up or treatment.Additional information received from the initial reporter on (b)(6) 2020 stated that the catheter was curled and kinked within the bladder.

• Brand Name: PVC FEEDING TUBE 5 FR 16IN
• Common Device Name: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• MDR Report Key: 10192613
• Report Number: 9612030-2020-02507
• Device Sequence Number: 16826651
• Product Code: KNT
• UDI-Device Identifier: 10884521067356
• UDI-Public: 10884521067356
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/24/2020

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
• Operator of Device: No Information
• Device Expiration Date: 07/31/2021
• Device Model Number: 460802
• Device Catalogue Number: 460802
• Device Lot Number: 1918305664
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 06/24/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 1 MO
• Patient Weight: 3