MAUDE Adverse Event Report: CARDINAL HEALTH JP PERF DRN SIL FLT 7MM FULL; CATHETER, IRRIGATION

Model Number	SU130-1310
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	12/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not received for evaluation; therefore, the affected device could not be evaluated to confirm the reported failure.The device history record (dhr) for the finished good was reviewed and no incident was documented that could have caused this type of non-conformance.No product discrepancies were found during the manufacturing of this lot.Root cause for the reported concern cannot be identified with the amount of information available.According to the instructions for use (ifu), ¿drains or tubing should not be handled with any instruments.This can lead to tearing, warping, or weakening and subsequent breakage of the drain.To facilitate removal of the drain, the drain and tubing portions should not be curled, pinched, over-stretched or sutured; either internally or externally.Do not suture the drain(s).Drains should be placed and removed carefully by hand only with a slow, steady pressure.Excessive force may result in breakage.During placement and removal of the drain, do not nick, cut, tear or otherwise damage the drain as this may lead to breakage.Leaving the drain implanted for any period of time which allows for tissue ingrowth around the drain may cause breakage on removal.We will continue to monitor related reports to determine if additional actions are necessary.
Event or Problem Description
Patient underwent a bifrontal craniotomy.While the jp drain that was placed during surgery was being removed at the bedside, the drain tubing snapped.Ct of head showed a radiopaque tubular structure in the frontal scalp with irregularity of a portion of the drain on the left, where there was previously extension of the catheter tubing through the temporal scalp and outside of the skin.Patient was taken to the or for removal of this retained catheter fragment.Fragment successfully removed.

• Brand Name: JP PERF DRN SIL FLT 7MM FULL
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH; 3651 birchwood drive; waukegan IL 60085
• Manufacturer (Section G): CARDINAL HEALTH; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 21370329
• Report Number: 1423537-2025-00075
• Device Sequence Number: 12902716
• Product Code: GBX
• UDI-Device Identifier: 10192253022360
• UDI-Public: (01)10192253022360(11)240606(17)290630(10)1240765
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 02/12/2025

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
• Device Model Number: SU130-1310
• Device Catalogue Number: SU130-1310
• Device Lot Number: 1240765
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/12/2025
• Date Device Manufactured: 01/06/2024
• 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: Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Male
• Patient Weight: 77 KG