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

Model Number 460802

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/15/2020

Event Type  Injury  

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 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
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 125 cuidad ind; tijuana 22500 ; MX 22500
• Manufacturer Contact: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 10192613
• MDR Text Key: 197566626
• Report Number: 9612030-2020-02507
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 10884521067356
• UDI-Public: 10884521067356
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/02/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 1 MO
• Patient Weight: 3