MAUDE Adverse Event Report: CORDIS CORPORATION 4F TEMPO AQUA .038" 125CM VERT; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	SRD6108
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This device is available for analysis but has not yet been received.A device history record review was performed and showed that these lots of products met all requirements per the applicable manufacturing quality plan.Additional information is pending and will be submitted within 30 days upon receipt.
Event or Problem Description
The luer lock fitting on the 4f tempo aqua.038" 125cm vert diagnostic catheter was not engaging properly with the syringe and was thus leaking.The procedure was successfully completed and there was no patient injury.The device will be returned for analysis.The procedure being performed was peripheral interventions on the legs.The leakage was noted when flushing the device.The user continued to use it and tried to stop/minimize the leaking.No additional patient or procedural details are available.
Additional Manufacturer Narrative
The luer lock fitting on the 4f tempo aqua.038" 125cm vert diagnostic catheter was not engaging properly with the syringe and was thus leaking.The procedure was successfully completed and there was no patient injury.The procedure being performed was peripheral interventions on the legs.The leakage was noted when flushing the device.The user continued to use it and tried to stop/minimize the leaking.No additional patient or procedural details are available.The device was not returned for analysis as it was discarded after the case.A product history record (phr) review of lot 17833134 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device for analysis, the reported customer event ¿luer hub ¿ catheters - incompatibility/fit - with syringe¿ could not be confirmed and the exact root cause could not be determined.Procedural/handling factors may have contributed to the reported event.Per the instructions for use (ifu), which is not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.For all catheters: keep the catheter filled with either flushing solution or contrast medium while the catheter is in the vascular system and consider the use of systemic heparinization.Forcibly aspirate and flush the catheter with heparinized saline solution at least once every two minutes.¿ neither the phr review nor the information available suggests that the reported failure could be related to the manufacturing process of the unit.Therefore, no corrective or preventative actions will be taken at this time.

• Brand Name: 4F TEMPO AQUA .038" 125CM VERT
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th ave,; miami lakes FL 33014
• MDR Report Key: 8890745
• Report Number: 9616099-2019-03143
• Device Sequence Number: 2534226
• Product Code: DQO
• UDI-Device Identifier: 20705032049785
• UDI-Public: 20705032049785
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K000579
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: SRD6108
• Device Catalogue Number: SRD6108
• Device Lot Number: 17833134
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/15/2019
• Supplement Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 08/13/2019
• Supplement Report FDA Received Date: 09/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1