MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,SILI-ELAST,LTX,24FR,10ML

Catalog Number DYND11764

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/15/2024

Event Type  Injury  

Event Description

According to the facility on 03/15/24 during a suprapubic catheter exchange the old catheter would not deflate.

Manufacturer Narrative

According to the facility on 03/15/24 during a suprapubic catheter exchange the old catheter would not deflate.Per the facility the catheter remained anchored and could not be removed.Per the facility the resident was sent to their urologist for an emergency visit where they experienced a "moderate amount of bleeding due to trauma of removal".Per the facility the resident is well.The sample is not available for evaluation.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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.

• Type of Device: CATHETER,FOLEY,SILI-ELAST,LTX,24FR,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: 19052296
• MDR Text Key: 339553126
• Report Number: 1417592-2024-00465
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10080196726561
• UDI-Public: 10080196726561
• 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: 04/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND11764
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/15/2024
• Initial Date FDA Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other