MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP Medline; TRAY,FOLEY,100% SIL,16FR 10ML

Model Number DYND11523

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 10/30/2022

Event Type  Injury  

Manufacturer Narrative

According to the customer contact, on (b)(6) 2022, 'foley catheter in place, balloon deflated and foley catheter found out of patient'.The catheter was in place due to the use of an epidural and was in place for 4 hours when the event was noticed.A new catheter was placed due to the reported incident with 'no complications noted'.The sample is available but has not been returned for evaluation.No additional information is available at this time.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer contact, on (b)(6) 2022, 'foley catheter in place, balloon deflated and foley catheter found out of patient'.

• Brand Name: Medline
• Type of Device: TRAY,FOLEY,100% SIL,16FR 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: justin herrmann ; three lakes drive; northfield, IL 60093
• MDR Report Key: 15868999
• MDR Text Key: 304347433
• Report Number: 1417592-2022-00230
• Device Sequence Number: 1
• Product Code: OHR
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: DYND11523
• Device Catalogue Number: DYND11523
• Device Lot Number: 220BF345
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other