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

Catalog Number DYND11003

Device Problems Deflation Problem (1149); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2018

Event Type  Injury  

Manufacturer Narrative

It was reported that a home care customer had a catheter placed on the morning of (b)(6) 2018.The customer service representative reported that while the caregiver was helping the customer get ready for bed on the same night ((b)(6) 2018), the caregiver rolled the customer over and the customer felt a pain in the area of the catheter placement; however, did not know why the pain occurred.The next morning the customer noticed the catheter fell out and the balloon of the catheter appeared to be popped.The customer's caregiver was a nurse and there was another catheter that was available in the home, so the nurse replaced the catheter without further incident.The catheters are stored in the closet at the customer's home.The actual sample was returned to the manufacturer for evaluation and the customer reported issue was confirmed; however, a root cause could not be determined at this time.There was no serious injury, follow-up medical care or additional medical intervention required related to the incident; however, medical intervention to replace the foley catheter was necessary.Due to the reported need for foley catheter re-insertion and in an abundance of caution, this medwatch is being filed.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that while inserted in patient, the foley catheter's balloon deflated resulting in the foley catheter falling out from the patient.

• Type of Device: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093 ; 8476434960
• MDR Report Key: 8055025
• MDR Text Key: 126658181
• Report Number: 1417592-2018-00117
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND11003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR
• Patient Weight: 118