MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO JP PERF DRN SIL FLT 10MM FULL; CATHETER, IRRIGATION

Model Number	SU130-1311
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/11/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample was not received for evaluation.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 these lots.The non-conformance report (ncr) data since october 2023 to present was reviewed and no issues that could be related to the condition reported were found.The lot number 1240323 was manufactured on march 22,2024 and the lot number 1240326 was manufactured on march 27,2024.This catalog is for single use only.Root cause for the reported concern cannot be identified with the amount of information available.
Event or Problem Description
On (b)(6) 2024, the bedside nurse and her orientee were discontinuing jp drain from patient's left leg vein graft site per protocol.Nurse felt slight resistance consistent with typical jp drain removal.Bulb removed to ensure no vacuum present and continued to remove jp drain.Flexible connecting tubing suddenly sheared off from connection site to drainage tubing.Drainage tubing stayed inside patient's vein graft site, unable to visualize.(b)(6) notified me and i also couldn't visualize the end of the drainage tubing still inside the patient's leg.Surgeon gave a small amount of local anesthetic at the site where the drain was exiting the patient¿s leg.Uitrasound was used to visualize the retained portion of the drain and a tonsil clamp was inserted into the existing incision and retained portion was pulled out from there.The customer is unsure if the device had a lot number of 1240323 or 1240326.
Additional Manufacturer Narrative
A supplemental report is being filed following the submission of the initial mdr report 1423537-2024-00306 since a sample was returned for evaluation.A customer unit was received, but the returned unit was a 100cc reservoir, not a flat drain.The unit was not received in its original packaging and it was not the product described in the complaint.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 both lots referenced in the description.The non-conformance report (ncr) data since december 2023 to present was reviewed and no issues that could be related to the condition reported were found.The lot number 1240323 was manufactured on march 22,2024 and the lot number 1240326 was manufactured on march 27,2024.This catalog is for single use only.Root cause for the reported concern cannot be identified since the returned unit was not the product that is described in the reported complaint.No actions taken, since no evidence of a manufacturing issue was found.

• Brand Name: JP PERF DRN SIL FLT 10MM FULL
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer (Section G): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• Manufacturer Contact: jill saraiva ; 3651 birchwood drive; waukegan, IL 60085 ; 5086183640
• MDR Report Key: 20690582
• Report Number: 1423537-2024-00306
• Device Sequence Number: 20629990
• Product Code: GBX
• UDI-Device Identifier: 10192253022377
• UDI-Public: 10192253022377
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/30/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: SU130-1311
• Device Catalogue Number: SU130-1311
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2024
• 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: Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 35 KG