MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML

Model Number	DYND11756
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2020 while removing a silicone elastomer coated latex foley cather from a (b)(6) female patient with neurogenic bladder the catheter broke into pieces.The reporter states, the catheter had been in place for three weeks prior to removal and had been inflated with 10 ml of sterile saline at time of insertion.Reporter states, there was bleeding at the site, but no serious injury noted.Reporter states, supervisor was contacted immediately.A new foley catheter was subsequently re-inserted without reported issue.The end user is currently "doing well, with no new issues at this time." the sample is not available for return and evaluation.Therefore, a root cause cannot be determined.No further information is available.Due to the reported incident and in abundance of caution this medwatch is being filed.If additional relevant information becomes available, this report will be reopened and reevaluated.
Event or Problem Description
It was reported that a silicone elastomer coated latex foley catheter broke into pieces upon removal.A new catheter was inserted.

• Brand Name: MEDLINE
• Common Device Name: CATHETER,FOLEY,SILI-ELAST,LTX,16FR,10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10532600
• Report Number: 1417592-2020-00096
• Device Sequence Number: 2562231
• Product Code: EZL
• UDI-Device Identifier: 10080196726523
• UDI-Public: 10080196726523
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11756
• Device Catalogue Number: DYND11756H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2020
• Initial Report FDA Received Date: 09/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 54 YR
• Patient Weight: 44