MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5FX60CM SNGL PRO LINE CT; PRO-LINE CT

Model Number	MR28035101
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The 5f cvc was returned for evaluation.Visual inspection revealed what appears to be a cut on the extension near the luer.Device was forwarded to medcomp engineering for review.
Event or Problem Description
During ct injection with the 5f pro-line, a leak was detected at the junction of the luer and extension tubing.No adverse clinical consequences to the patient were reported.
Additional Manufacturer Narrative
Visual inspection of the returned device revealed a tear on the extension at the edge of the luer that leaks when the device is flushed.The device was examined under a microscope and measurements of the extension profile were taken.The extension diameters were found to be within specification.The luer was dissected to determine where the tear originated.The tear ended at the bottom of the luer and did not extend into the luer.There are no signs of the extension ballooning or elongating.There is no other visible damage or defect to the returned sample.The catheter was implanted for two days before the failure occurred.Visual inspection and flushing of the catheter during placement would have identified any external damage to the catheter caused during manufacturing or transit.The extension was found to have dimensions within specification and there were no signs of damage to the extension within the overmolded luer, identifying the failure did not originate from manufacturing.The use of sharps around the catheter luer and extension may have contributed to the failure.A definitive root cause cannot be determined.

• Brand Name: 5FX60CM SNGL PRO LINE CT
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 9278624
• Report Number: 2518902-2019-00068
• Device Sequence Number: 2388862
• Product Code: LJS
• UDI-Device Identifier: 00884908034608
• UDI-Public: 884908034608
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K093309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/16/2022
• Device Model Number: MR28035101
• Device Catalogue Number: MR28035101
• Device Lot Number: MNJR410
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 12/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention