MINICAP TRANSFER SET

MDR report key: 16087575 · Received January 3, 2023

Report

Report Number: 1416980-2022-07190
Event Type: Malfunction
Date Received: January 3, 2023
Date of Event: December 6, 2022
Report Date: January 25, 2023
Manufacturer: BAXTER HEALTHCARE CORPORATION
Product Code: KDJ
UDI-DI: 00085412007731
PMA / PMN Number: K152675
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SC, US
Reporter Occupation: NURSE
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 0

CORRECTION MADE TO D5: OPERATOR OF DEVICE: PATIENT/CONSUMER (PREVIOUSLY SUBMITTED AS HEALTH PROFESSIONAL) CORRECTION MADE TO G4: PMA/510K #: K152675 (PREVIOUSLY SUBMITTED AS K851207). B5: THE PATIENT RECEIVED PROPHYLACTIC CARE TO PREVENT CONTAMINATION. H10: A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS DISCARDED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 0

IT WAS REPORTED THAT THE FEMALE CONNECTOR OF A MINICAP TRANSFER SET WAS SEPARATED FROM THE MAINBODY OF THE TWIST CLAMP. IT WAS FURTHER DESCRIBED AS "THE DARK BLUE PART OF THE TRANSFER SET HAS COME APART AND AWAY FROM THE LIGHT BLUE END WHEN DISCONNECTING THE CAP/LINE". TO RESOLVE THIS ISSUE, THE TRANSFER SET WAS REPLACED. THIS OCCURRED DURING UNSPECIFIED PROCESS STEP OF PERITONEAL DIALYSIS THERAPY. THERE WAS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
132264	MINICAP TRANSFER SET	SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE	KDJ	BAXTER HEALTHCARE CORPORATION	NA	H22C10064	00085412007731

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown		NI.