MAUDE Adverse Event Report: PR006 PUERTO RICO-ANASCO DRAIN JACKSON PRATT RND7FR END; CATHETER, IRRIGATION

Model Number	SU130-1320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
the customer sample was not available for evaluation.It is vital to the investigation that the customer sample be available for examination and testing.   as no lot number was provided, we were unable to trace the dhr, quality testing performed and corresponding results.The ncr data since august 2020 to present was reviewed and no issues that could be related to the catalog and condition reported were found.   root cause for the reported concern cannot be identified with the amount of information available.   as preventive actions, the customer will be provided with a copy of the instructions for use.It is recommended to strictly follow the instructions provided in the instruction for use (ifu) data included with the product to ensure drains are properly used.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 and into the holes, may cause breakage on removal.¿   we will continue to monitor trends and utilize the information as part of continuous improvement. .
Event or Problem Description
Patient was with severe stenosis at the l4-5 segment in the setting of spondylolisthesis as well as osteoporosis.Went to the or for spinous process-splitting laminoplasty of l4, decompression of the l4-5 interspace with partial medial facetectomy bilaterally, l5-s1 foraminotomies bilaterally, and 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.The next day, surgical drain was removed at the bedside that morning.After removal, reportedly there were only two fenestrations in the end of the drain visualized.The patient was taken to the or 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 RND7FR END
• Common Device Name: CATHETER, IRRIGATION
• Manufacturer (Section D): PR006 PUERTO RICO-ANASCO; state rd. 402 , north km 0.9; anasco PR 00610
• MDR Report Key: 12363241
• Report Number: 1423537-2021-00666
• Device Sequence Number: 3822154
• Product Code: GBX
• UDI-Device Identifier: 10192253022391
• UDI-Public: 10192253022391
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/24/2021

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
• Operator of Device: Health Professional
• Device Model Number: SU130-1320
• Device Catalogue Number: SU130-1320
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/30/2021
• Initial Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 82