MAUDE Adverse Event Report: COVIDIEN DOVER; KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER

Model Number 7016LL

Device Problem Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/05/2018

Event Type  Injury  

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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the patient had a foley catheter placed due to difficulty voiding after previous surgeries.Less than 12 hours post insertion, the nurse tried to deflate the balloon with a syringe, but the balloon would not deflate.The nurse then tried to cut the fill port and the balloon still did not drain.A urology md was brought to the department to try to manipulate the foley to get it to drain, however, was unable to do so.The patient had to be taken into surgery to have the foley catheter removed.

• Brand Name: DOVER
• Type of Device: KIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER
• Manufacturer (Section D): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): COVIDIEN; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7359848
• MDR Text Key: 103137000
• Report Number: 9612030-2018-00034
• Device Sequence Number: 1
• Product Code: FCN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7016LL
• Device Catalogue Number: 7016LL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other