FDA Adverse Event Malfunction Summary report: N

PORTEX GENERAL ANESTHESIA CIRCUITS

MDR report key: 14427582 · Received May 18, 2022

Report

Report Number: 3012307300-2022-08946
Event Type: Malfunction
Date Received: May 18, 2022
Date of Event: April 1, 2022
Report Date: December 15, 2022
Manufacturer: SMITHS MEDICAL INTERNATIONAL, LTD.
Product Code: CAI
UDI-DI: 00351688433469
PMA / PMN Number: K002506
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. THREE (3) PICTURES WERE ATTACH, DURING THE ANALYSIS CONDUCTED IT COULD BE OBSERVED A TOP VIEW OF A CIRCUIT BREATHING INSIDE OF SEALING PACKAGING, ONE OF THEM IS MADE A FOCUS AN THE CONNECTOR WHERE A STAIN IS OBSERVED. VISUAL INSPECTION RESULTS: THE BAG OF THE CIRCUIT BREATHING IS SEALED AND A STAIN ON A CONNECTOR WAS DETECTED INSIDE OF IT; THUS, THE FAILURE MODE REPORTS IS CONFIRMED. THE OCCURRENCE OF THIS FAILURE CONDITION COULD BE CAUSED BY: UNCLEAN WORK STATION. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCESS. A DHR (DEVICE HISTORY REVIEW) WAS PERFORMED AND NO PROBLEMS OR ISSUES WERE IDENTIFIED DURING THIS DHR REVIEW., CORRECTED DATA: GMDN: 37704; D3: MFG. NAME: HYTHE; D4: UDI#: (B)(4) ; G5: (510K) NR: K002506; H4: DEV MFG. DATE: 17-NOV-2021; D4: DEV. EXP. DATE: 06-NOV-2024.

Description of Event or Problem · 0

IT WAS REPORTED THAT BEFORE OPENING THE PACKAGE, THE CUSTOMER FOUND A STAIN ON THE CONNECTOR. NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2753528	PORTEX GENERAL ANESTHESIA CIRCUITS	CIRCUIT, BREATHING (W CONNECTOR, ADAPTOR, Y PIECE)	CAI	SMITHS MEDICAL INTERNATIONAL, LTD.	C1034J	4218309	00351688433469

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown