TEMPO

Report

Report Number: 9616099-2024-00316
Event Type: Malfunction
Date Received: September 24, 2024
Date of Event: September 11, 2024
Report Date: November 7, 2024
Manufacturer: CORDIS US CORP
Product Code: DQO
UDI-DI: 10705032008464
PMA / PMN Number: K973401
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. FOUR PHOTOS WERE ATTACHED TO THE EVENT-2024-10021. IN THE PHOTOS, A 5F DX UNIT IS OBSERVED, APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY, BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF WHERE THE ANOMALIES OBSERVED ARE, IF INSIDE OR OUTSIDE THE PACKAGING, COULD NOT BE DETERMINED WITH THE PICTURES PROVIDED. NO OTHER OUTSTANDING DETAILS NOR ANOMALIES COULD BE OBSERVED. A STERILE UNIT OF CATHETER CATH TEMPO 5F VER 135° 100CM WAS RECEIVED COILED INSIDE OF A CLEAR PLASTIC BAG. THE DEVICE WAS UNPACKED TO PROCEED WITH THE PRODUCT EVALUATION. DURING THE VISUAL INSPECTION, KINKED/BENT CONDITIONS WERE OBSERVED ON THE UNIT, HOWEVER THOSE KINKS COINCIDE WITH THE FOLDS MADE IN THE UNIT FOR IT TO BE PLACED IN THE PLASTIC BAG. NO OTHER DAMAGES OR ANOMALIES WERE OBSERVED ON THE RETURNED DEVICE AT NAKED EYE. FOR THE KINKED/BENT CONDITION FOUND ON THE UNIT, NO DIMENSIONAL ANALYSIS WAS PERFORMED SINCE THE DAMAGES WERE CAUSED DUE THE FOLDING OF THE UNIT TO BE SHIPPED. FUNCTIONAL ANALYSIS WAS PERFORMED. FLUSHING TEST WAS PERFORMED ON THE UNIT RETURNED. NO ANOMALIES, SUCH AS LEAKAGE, OBSTRUCTION, NOR DIFFICULTIES WERE NOTED IN ANY OF THE COMPONENTS OF THE UNIT. THE UNIT WAS INSPECTED USING THE VISION SYSTEM. THE ENTIRE LENGTH AND COMPONENTS WERE INSPECTED USING THE SYSTEM. A BLACK SPOT WAS FOUND ON THE BODY OF THE UNIT, THIS BLACK SPOT LOOKED INCRUSTED ON THE MATERIAL OF THE BODY AND, NO ALTERATION WAS FELT TO THE TOUCH ON THE SURFACE; NEITHER A PROTRUSION NOR A DENT IN THE MATERIAL. A BLACK LINE WAS ALSO FOUND ON THE HUB OF THE UNIT, THE LINE WAS OBSERVED NEAR THE NUMBER 5 PRINTED ON THE HUB. NO ALTERATION WAS FELT TO THE TOUCH ON THE SURFACE; NEITHER A PROTRUSION NOR A DENT IN THE MATERIAL. THEREFORE, THE DEFECT OBSERVED IS AN INK STAIN FROM THE PAD PRINTER PROCESS. DIMENSIONAL ANALYSIS WAS PERFORMED TO VERIFY THE SIZE OF THE BLACK SPOTS FOUND ON THE MICROSCOPICAL ANALYSIS, TO BE VERIFIED. DIMENSIONAL ANALYSIS RESULTS WERE FOUND WITHIN SPECIFICATION SINCE ACCORDING TO THE DOCUMENT REFERENCED THE SPOT ON THE CATHETER CAN BE ACCEPTED IF IS LESS THAN OR EQUAL TO 0.050¿. IN THIS CASE THE SPOT FOUND IS AROUND 0.020¿. THE EVENT REPORTED BY THE CUSTOMER AS ¿LUER HUB - DAMAGED¿ WAS NOT CONFIRMED AS NO DAMAGE WAS NOTED ON THE COMPONENT. HOWEVER, A BLACK LINE WAS OBSERVED NEAR THE NUMBER 5 PRINTED ON THE HUB. THIS LINE WAS IDENTIFIED AS AN INK STAIN FROM THE PAD PRINTING PROCESS, WITH NO SURFACE ALTERATIONS SUCH AS PROTRUSIONS OR DENTS. THE OBSERVED INK STAIN IS ACCEPTABLE ACCORDING TO QUALITY STANDARD. THE EVENT REPORTED BY THE CUSTOMER AS ¿CATHETER (BODY/SHAFT) - FOREIGN MATERIAL¿ WAS CONFIRMED SINCE A BLACK SPOT WAS FOUND EMBEDDED IN THE BODY OF THE UNIT. ALTHOUGH THE BLACK SPOT ON THE CATHETER BODY IS MANUFACTURING-RELATED, IT FALLS WITHIN ACCEPTABLE QUALITY STANDARDS. THE BLACK SPOT'S SIZE IS WELL BELOW THE MAXIMUM ALLOWABLE THRESHOLD, WITHOUT AFFECTING THE FUNCTION OR SAFETY OF THE DEVICE. ALTHOUGH THIS DEVICE FALLS WITHIN SPECIFICATION, ANY DEFICIENCY RELATED TO IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS, OR PERFORMANCE SHOULD BE REPLACED AND THE AFFECTED DEVICE SHOULD BE SENT BACK FOR EVALUATION. GIVEN THE ADHERENCE TO QUALITY SPECIFICATIONS AND THE LACK OF FUNCTIONAL IMPACT, NO CORRECTIVE ACTIONS WILL BE TAKEN.

Additional Manufacturer Narrative · 0

THE DEVICE WAS RECEIVED FOR ANALYSIS, BUT THE ENGINEERING REPORT IS NOT YET AVAILABLE. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

Description of Event or Problem · 0

AS REPORTED, UPON RECEIPT OF A SHIPMENT OF 5F 100 CM TEMPO VERTEBRAL CONTRAST CATHETERS, SCRATCHES WERE FOUND ON THE INSIDE OF ONE OF THE CATHETERS. ADDITIONALLY, BLACK SPOTS WERE FOUND ON THE BODY OF FOUR (4) OTHER CATHETERS, WHICH WERE SUSPECTED TO BE CONTAMINATED. THE CONDITION WAS NOTED AFTER THE PRODUCT HAD BEEN RECEIVED AND STORED IN THE LAB, PRIOR TO USE. THERE WAS NO REPORTED PATIENT INJURY. THERE WERE NO DAMAGES TO THE PACKAGING OR DEVICE. THE DEVICES WERE STORED AS PER THE INSTRUCTIONS FOR USE (IFU) IN THE STERILE PROCESSING DEPARTMENT (SPD) WAREHOUSE AND PRODUCT CABINETS. NONE OF THE STERILE POUCHES RECEIVED WERE OPEN OR COMPROMISED. THE INNER PACKAGE SEAL WAS NOT OPENED IN ANTICIPATION OF USE AND THEN RESHELVED. PICTURES WERE PROVIDED FOR REVIEW. THE PICTURES WERE REVIEWED AND APPARENT SCRATCHES ARE OBSERVED ON THE CENTRAL SECTION OF THE HUB. ADDITIONALLY BLACK PARTICLES ARE OBSERVED ON THE BODY OF THE UNIT. THE POSITION OF THE ANOMALIES OBSERVED, EITHER INSIDE OR OUTSIDE THE PACKAGING COULD NOT BE DETERMINED ON THE PICTURES PROVIDED. THE DEVICES WERE RETURNED FOR EVALUATION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2015981	TEMPO	CATHETER, INTRAVASCULAR, DIAGNOSTIC	DQO	CORDIS US CORP		18319158	10705032008464

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Unknown