MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 12.5FX24CM HEMO-CATH; LT HEMO-CATH

Model Number	DMC101243
Medical Device Problem Code	Air/Gas in Device (4062)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
The blue lumen of the apheresis line was accessed per policy.The red lumen of the catheter was noted to have air in it.Patient stated that there was air observed in the line the week before also.She denies the cap coming off or any notable leakage.No cracks were visible in the line by the apheresis unit nurses or surgery team who came to consult when the air was discovered.Dressing removed by surgery team, heparin dwell removed, and line flushed with ns while the general surgery resident, pa and rn watched for leaking.No leaks noted.Due to unexplained recurrence of air in the line and risk for harm, a plan was made for the central line to be removed in the or.The line was removed without complications but the line was not saved by the surgery team in the or so we are unable to sequester the line for examination by the company.
Additional Manufacturer Narrative
The complaint was received in the mail in the form of a medwatch from the facility.The report indicated the device was not saved therefore cannot be returned for an evaluation.The contract manufacturer conducted a review of the manufacture records for the lot number reported.Their investigation revealed the device was manufactured according to specification with no nonconformances or other abnormalities associated with the device.There were no deviations or process changes in the manufacturing of this device.All inspections and sequence of operations were properly followed and documented.Without an evaluation of the device a root cause cannot be determined.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 12.5FX24CM HEMO-CATH
• Common Device Name: LT HEMO-CATH
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• MDR Report Key: 11674733
• Report Number: 2518902-2021-00021
• Device Sequence Number: 11538224
• Product Code: MSD
• UDI-Device Identifier: 00884908140835
• UDI-Public: 884908140835
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K113487
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: User Facility
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2021

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 05/21/2025
• Device Model Number: DMC101243
• Device Catalogue Number: DMC101243
• Device Lot Number: MPAM760
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 04/15/2021
• Initial Report FDA Received Date: 04/15/2021
• Supplement Report FDA Received Date: 04/21/2021
• 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: Required Intervention
• Patient Age: 20 YR
• Patient Weight: 90