AUTOSOFT XC

MDR report key: 19663163 · Received July 3, 2024

Report

Report Number: 3003442380-2024-11450
Event Type: Malfunction
Date Received: July 3, 2024
Date of Event: February 20, 2024
Report Date: July 3, 2024
Product Code: FPA
UDI-DI: 05705244016620
PMA / PMN Number: K032854
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

INITIAL AND FINAL MDR 1925716 - MDR 3003442380-2024-11450 - DEVICE 2 OF 10.

Description of Event or Problem · 0

UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN THE UNITED STATES. ON (B)(6) 2024, IT WAS REPORTED THAT THE TEN INFUSION SET CANNULA WAS KINKED AND PATIENT FACES SYMPTOMS WITHIN 3 OR MORE HOURS AFTER INSERTION. THE SITE OF INSERTION IS ABDOMEN, UPPER BUTTOCKS & THIGH AND INFUSION SET IS LONG FOR 12 HOURS. THE BLOOD GLUCOSE LEVEL WAS 300 MG/DL. UNOMEDICAL DO NOT SEE BENT/KINKING AS BEING RELATED TO HUMAN FACTORS, BUT RATHER AS A TRAINING ISSUE INCLUDING CORRECT CHOICES OF INSERTION SITES AND INFUSION SETS AND CANNULA LENGTH. FURTHERMORE, THE SOFT CANNULA IS A FLEXIBLE MATERIAL THAT DURING USE AND UPON REMOVAL CAN BEND SLIGHTLY. NO FURTHER INFORMATION AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
800158	AUTOSOFT XC	UNO INSET I 60/6 GREY TCAP 10PK INT	FPA		1001680	6002634	05705244016620

Patients

Seq	Age	Sex	Outcome	Treatment
1	23 YR	Female