MAUDE Adverse Event Report: CARDINAL HEALTH 200, LLC DRAIN JACKSON PRATT; CATHETER, IRRIGATION

Model Number SU130-1320

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907); Appropriate Term/Code Not Available (3191)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/18/2021

Event Type  Injury  

Event Description

Patient with severe stenosis at the l4-5 segment in the setting of spondylolisthesis as well as osteoporosis.Went to the operating room for spinous process-splitting laminoplasty of l4.Decompression of the l4-5 interspace with partial medial facetectomies bilaterally.L5-s1 foraminotomies bilaterally.Repair of dural deficiency over the right side of the l4-5 lateral recess utilizing 6-0 gore-tex suture and duraseal sealant.A closed suction drain was inserted during the procedure.The next day, surgical drain was removed at the bedside that morning.After removal, there were only two fenestrations in the end of the drain visualized.The patient was taken to the operating room and previous sutures were removed.Deep dermal sutures were also removed bring the fascia into view.The fascial layer remained nicely approximated and closed.In the distal aspect of the previous fascial opening, the remaining drain fragment was easily identified.This was successfully removed whole with the assistance of a needle driver.The wound was inspected and copiously irrigated with sterile saline.

• Brand Name: DRAIN JACKSON PRATT
• Type of Device: CATHETER, IRRIGATION
• Manufacturer (Section D): CARDINAL HEALTH 200, LLC; 3651 birchwood drive; waukegan IL 60085
• MDR Report Key: 12173037
• MDR Text Key: 261701306
• Report Number: 12173037
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/12/2021

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
• Device Operator: No Information
• Device Model Number: SU130-1320
• Device Catalogue Number: SU130-1320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/12/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/15/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 29930 DA