MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 5F X 55CM DL PROLINE CT-CUFF@5CM; PRO-LINE CT

Model Number	MD28035201
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Date of Event	12/14/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Device initially implanted at a facility in the usa.Patient then returned home to (b)(6)."fistula at the point of insertion of the catheter through which the medicine was drained.The catheter had a fissure, it produced an infection.To extract it, it was cut where the fissure was and a blood culture was performed on the part that was inside the body, showing positive for staphylococcus coagulase negative.".
Additional Manufacturer Narrative
Our investigation is ongoing.A follow up report will be submitted when the investigation is complete.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
No device was returned for evaluation.X-ray and photograph provided are not sufficient to evaluate the issue.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured, tested, and inspected according to specification with no non-conformances or abnormalities.The process includes a 100% leak test performed as a last step in the process.This test would have revealed any hole, ruptures, tears, or small pin holes that could cause the device to leak if it had existed at the time of manufacture.Without an evaluation of the device a root cause cannot be determined.The report indicated that when the catheter was removed the internal part of the lumen was cultured and was part that positive for staphylococcus coagulase negative.This is a staph bacteria that commonly live on a person's skin.The presence of an intravascular catheter increases the risk of an infection from this organism.The instructions for use (ifu) contains the following precautions that if followed will minimize the occurrence of hole/tears, leaks in the catheter.Small syringes will generate excessive pressure and may damage the catheter.Ten (10)cc or larger syringes are recommended.Do not use sharp instruments near the extension lines or catheter lumen.Do not use scissors to remove dressing.The maximum recommended infusion rate is 5cc/sec.The maximum pressure of power injectors used with the pro-line® ct power injectable cvc may not exceed 300psi.Exceeding the maximum flow rate of 5cc/sec may result in catheter failure and/or catheter tip displacement.Contrast media should be warmed to body temperature prior to power injection.Warning: failure to warm contrast to body temperature prior to power injection may result in catheter failure.Failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 5F X 55CM DL PROLINE CT-CUFF@5CM
• Common Device Name: PRO-LINE CT
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 13384645
• Report Number: 2518902-2022-00012
• Device Sequence Number: 17010711
• Product Code: LJS
• UDI-Device Identifier: 00884908137484
• UDI-Public: 884908137484
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093309
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/16/2022

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: 11/04/2023
• Device Model Number: MD28035201
• Device Catalogue Number: MD28035201
• Device Lot Number: MPHB820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2022
• Supplement Date Received by Manufacturer: 01/03/2022
• Initial Report FDA Received Date: 01/28/2022
• Supplement Report FDA Received Date: 02/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 8 YR
• Patient Sex: Female
• Patient Weight: 38 KG