MAUDE Adverse Event Report: COVIDIEN TRAY,FOLEY,16FR,5CC ULTRAMER LATEX CAT; CATHETER, URETERAL, GASTRO-UROLOGY

Model Number 6165LL

Device Problem Deflation Problem (1149)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

Submit date: 9/24/2018.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.

Event Description

Customer reports: the foley catheter got stuck about one inch from the urethra as it was being taken out of the patient.The nurse had attempted to deflate the balloon and did not get anything back, so the foley was pulled until it got stuck.I attempted to deflate the balloon and did not get anything back, but could feel the balloon about one inch from the tip of his penis.We then cut the foley in an effort to drain the balloon but this did not work.A 27 gauge needle was used to deflate the balloon through the patient's skin and this was successful in removing the foley.

Manufacturer Narrative

The device history record (dhr) for lot number 705952464x indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.No product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.A root cause could not be determined.This complaint will be utilized for tracking and trending purposes.

• Brand Name: TRAY,FOLEY,16FR,5CC ULTRAMER LATEX CAT
• Type of Device: CATHETER, URETERAL, GASTRO-UROLOGY
• 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7903375
• MDR Text Key: 121514812
• Report Number: 9612030-2018-02017
• Device Sequence Number: 1
• Product Code: EYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 6165LL
• Device Catalogue Number: 6165LL
• Device Lot Number: 705952464X
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/05/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention