MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Model Number	DYND11003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "catheter was leaking at the penis." catheter was replaced.Email received by registered nurse, hospice of (b)(6) with information in regards to this incident.Reporter states, the original foley catheter (silicone-elastomer coated latex foley catheter) had been in place for seventeen days prior to this incident occurring.It was reported (b)(6) 2021 the foley catheter was replaced with a 16 fr.Silicone catheter.No report of serious injury.Sample is available and been requested for return however, at the time of submission of this report the sample has not been returned.Due to the reported incident, medical intervention 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 or Problem Description
It was reported, "catheter was leaking at the penis." catheter was replaced.
Additional Manufacturer Narrative
Supplemental documentation changed/additional information added.Device available for evaluation -yes, returned on 4/6/2021 type of report - follow-up, 01 if follow-up what type? additional information, device evaluation device evaluated by manufacturer - yes, evaluation summary attached.Investigation conclusion (b)(4) /unconfirmed defect.Investigation report reads as follows: 04/11/2021 21:42:02 cst (alu)" material number: dynd11003, sample and/or photo provided? sample (quantity provided: 1 ea).Lot number? 592200610.Defect(s) from complaint: leaking at insertion site.Investigation results: not confirmed.Investigation conclusion / root cause: "the reported issue of a leaking catheter could not be confirmed through functional evaluation of the received sample.Based on the description of the issue, some suspected root causes could be, but are not limited to, insertion method, patient specific condition, size of the catheter chosen, etc.".
Event or Problem Description
It was reported, "catheter was leaking at the penis." catheter was replaced.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11614527
• Report Number: 1417592-2021-00060
• Device Sequence Number: 3396879
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/27/2021

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: DYND11003
• Device Catalogue Number: DYND11003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/29/2021
• Supplement Date Received by Manufacturer: 03/29/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 09/27/2021
• 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: 78 YR
• Patient Weight: 50