FDA Adverse Event Malfunction Summary report: N

HYDROMID

MDR report key: 20886422 · Received December 9, 2024

Report

Report Number: 3015060232-2024-00029
Event Type: Malfunction
Date Received: December 9, 2024
Date of Event: November 12, 2024
Report Date: December 9, 2024
Manufacturer: ACCESS VASCULAR. INC.
Product Code: FOZ
UDI-DI: 00850030354358
PMA / PMN Number: K203069
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NH, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

THE COMPLAINANT REPORTED THAT THE MIDLINE CATHETER WAS REMOVED ON (B)(6) 2024 AFTER BEING IN PLACE FOR FOUR DAYS. A FRACTURE WAS OBSERVED UPON REMOVAL. THE COMPLAINANT IS A MOBILE PROVIDER AND STATED THAT THE SITE MAINTAINING THE LINE REPORTED THAT THE LINE WAS NOT WORKING 100% OF THE TIME AND THE PATIENT WAS EXPERIENCING SOME PAIN. THE MOBILE VASCULAR ACCESS NURSE DISCUSSED PROPER FLUSHING PROCEDURES WITH THE SITE, BUT WAS NOT SURE WHAT SIZE SYRINGE THE SITE WAS USING TO FLUSH THE LINE. THE SITE DID NOT IDENTIFY THE FACTURE WHEN THE LINE WAS REMOVED, BUT IT WAS IDENTIFIED BY THE MOBILE VASCULAR ACCESS NURSE. THE LINE WAS RETURNED TO AVI ON (B)(6) 2024. A BREAK WAS OBSERVED AT THE 4.0 CM MARK AND INDICATIONS OF PREVIOUS KINKS IN THE LINE WERE OBSERVED AT THE 2.8 CM, 4.8 CM, AND 5.5 CM MARKS. STRETCHED MATERIAL AT THE LOCATION OF THE BREAK INDICATED THAT THE BREAK WAS CAUSED BY INTERNAL PRESSURE. THE REVIEW OF THE LOT HISTORY RECORD DID NOT IDENTIFY ANY NONCONFORMANCES RELATED TO CATHETER PRODUCTION. THE BREAK IN THE LINE WAS CONFIRMED, BUT A ROOT CAUSE COULD NOT BE DETERMINED.

Description of Event or Problem · 0

REPORT OF A FRACTURED MIDLINE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2536200	HYDROMID	CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS	FOZ	ACCESS VASCULAR. INC.	MID-141CM	03082401	00850030354358

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown