MAUDE Adverse Event Report: COVIDIEN UNKNOWN FOLEY CATHETER; CATHETER, URETERAL, GASTRO-UROLOGY

Model Number UNK URO

Device Problem Deflation Problem (1149)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/07/2018

Event Type  Injury  

Manufacturer Narrative

Submit date: 5/29/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

Customer reports: the patient had a foley catheter inserted during labor and delivery.After delivery, the nursing staff attempted to remove the catheter by draining the balloon with a syringe.The balloon would not deflate.The staff then cut the fill port todrain the fluid from the balloon, but the balloon would not deflate.Finally, a md was called in and used a guidewire to pop the balloon which proved successful.

• Brand Name: UNKNOWN FOLEY CATHETER
• Type of Device: CATHETER, URETERAL, GASTRO-UROLOGY
• 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: 7550577
• MDR Text Key: 109449273
• Report Number: 9612030-2018-00097
• 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: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK URO
• Device Catalogue Number: UNK URO
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/15/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention