FDA Adverse Event Malfunction Summary report: N

MINICAP TRANSFER SET

MDR report key: 10643328 · Received October 7, 2020

Report

Report Number: 1416980-2020-06261
Event Type: Malfunction
Date Received: October 7, 2020
Date of Event: September 16, 2020
Report Date: November 11, 2020
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
PMA / PMN Number: K192705
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 0

D1 BRAND NAME: UPDATED TO MINICAP TRANSFER SET. D4 CATALOGUE #: FROM ASKU TO 5C4482. G5 PMA/510K #: FROM NI TO K192705. H10: THE DEVICE EVALUATION WAS COMPLETED. A VISUAL INSPECTION WITH THE NAKED EYE NOTED THE TUBING WAS SEPARATED FROM THE DARK BLUE FEMALE CONNECTOR. THE DARK BLUE FEMALE CONNECTOR WAS NOT RETURNED WITH THE TUBING. THERE WERE MARKINGS ON THE INSIDE OF THE TUBING WHERE THE FEMALE CONNECTOR HAD PREVIOUSLY BEEN ATTACHED. THE REPORTED CONDITION WAS VERIFIED. THE CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

THE DEVICE WAS RECEIVED AND IS CURRENTLY AWAITING EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE TUBING AND THE TWIST CLAMP OF THE TRANSFER SET HAD SEPARATED. THIS ISSUE OCCURRED DURING THERAPY FOR PERITONEAL DIALYSIS THERAPY. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1106551	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION	NA	ASKU

Patients

Seq	Age	Sex	Outcome	Treatment
1