MAUDE Adverse Event Report: FRESENIUS MEDICAL CARE NORTH AMERICA LUER LOCK 12IN; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Model Number 050-95005

Device Problems Leak/Splash (1354); Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 07/05/2023

Event Type  Injury  

Event Description

Extension set tip fell off.Patient noticed a leak.

• Brand Name: LUER LOCK 12IN
• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): FRESENIUS MEDICAL CARE NORTH AMERICA; waltham MA 02451
• MDR Report Key: 17327306
• MDR Text Key: 319122310
• Report Number: MW5119435
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2023
• Device Model Number: 050-95005
• Device Catalogue Number: 050-95005
• Device Lot Number: 22SR08086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 58 YR
• Patient Sex: Female
• Patient Weight: 90 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American