MAUDE Adverse Event Report: COOK IRELAND LTD COLON DECOMPRESSION SET; FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION

Model Number	G22181
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The inner catheter got stuck and snapped when taken out.The broken part was then finally pulled out.No patient injury.Product and package disposed of."as per cc form": the inner catheter got stuck and snapped when taken out.The broken part was then finally pulled out.No patient injury.Product and package disposed.A section of the device did not remain inside the patient¿s body.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Pma/510(k) # k171619.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.
Additional Manufacturer Narrative
Pma/510(k) # k171619.Device evaluation: 1 x cdsg-14-175 of lot number c1863002 involved in this complaint was not available for evaluation.Document review including ifu review: prior to distribution cdsg-14-175 devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.A review of the manufacturing records for cdsg-14-175 of lot number c1863002 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1863002.The instructions for use (ifu0102-4) states the following: ¿if package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ root cause review: a definite root cause cannot be determined as the device was not returned for evaluation and due to limited information.Engineering input could not determine could not determine what may have caused the catheter to get stuck and subsequently snap based on the information available.Several attempts have been made to obtain additional information from the customer, but this information has not been forthcoming, if it is received at a later date the investigation will be updated accordingly.Summary: complaint is based on customer testimony.According to the information reported, there was no adverse effects to the patient or additional procedures required.Complaints of this nature will continue to be monitored for potential emerging trends.
Event or Problem Description
Supplemental report is being submitted due to completion of the investigation.

• Brand Name: COLON DECOMPRESSION SET
• Common Device Name: FEG TUBE, DOUBLE LUMEN FOR INTESTINAL DECOMPRESSION AND/OR INTUBATION
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 13534106
• Report Number: 3001845648-2022-00083
• Device Sequence Number: 4227816
• Product Code: FEG
• UDI-Device Identifier: 00827002221819
• UDI-Public: (01)00827002221819(17)240830(10)C1863002
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/30/2024
• Device Model Number: G22181
• Device Catalogue Number: CDSG-14-175
• Device Lot Number: C1863002
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/17/2022
• Event Location: Hospital
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 01/20/2022
• Initial Report FDA Received Date: 02/15/2022
• Supplement Report FDA Received Date: 11/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2021
• 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
• Patient Sex: Unknown