MAUDE Adverse Event Report: FIRSTAR MEDICAL INDUSTRIAL LTD. JP 3-SPRING RES W/10FR PVC DRAIN/TR; APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED

Model Number	SU130-402D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
When removing a hemovac drain at the bedside (drain was placed in the operating room), part of the tubing broke off and was retained within the patient.Other information about the patient that may have influenced the outcome of the event: placement of four drains was rushed due to emergent and critical nature of patient's procedures.Patient has massive spinal trauma and had four drains placed in his back, during procedure it was rushed in order to get the patient on their back, instead of on their stomach while they operated on patient's spine, in case compressions were needed.
Additional Manufacturer Narrative
Based on supplier investigation, device history record (dhr) could not be reviewed as lot number was not provided.No sample was provided for investigation, therefore a root cause could not be determined.Supplier checked the barium tube from the inventory and there was no problem, as the breaking strength is greater than 4kg, which meets the standard.Supplier will continue to monitor for this type of issue.

• Brand Name: JP 3-SPRING RES W/10FR PVC DRAIN/TR
• Common Device Name: APPARATUS, SUCTION, SINGLE PATIENT USE, PORTABLE, NONPOWERED
• Manufacturer (Section D): FIRSTAR MEDICAL INDUSTRIAL LTD.; rm.901,building no.2, headquar; tian'an high-tech ecological p; panyu, guangzhou, 511493 ; CH
• Manufacturer (Section G): FIRSTAR MEDICAL INDUSTRIAL LTD.; rm.901,building no.2, headqu; tian'an high-tech ecological p; panyu, guangzhou, 511493 ; CH
• Manufacturer Contact: patricia tucker ; 3651 birchwood dr.; waukegan, IL 60085 ; 8478874151
• MDR Report Key: 18492255
• Report Number: 1423537-2024-00001
• Device Sequence Number: 19749165
• Product Code: GCY
• UDI-Device Identifier: 10192253016420
• UDI-Public: 10192253016420
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/11/2024
• Report Date (Section F): 12/26/2023

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: SU130-402D
• Device Catalogue Number: SU130-402D
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 12/26/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/26/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2023
• Initial Report FDA Received Date: 01/11/2024
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3900500000-2023-8012
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: White