MAUDE Adverse Event Report: COVIDIEN MFG SOLUTIONS S.A.; KIT, REPAIR, CATHETER, HEMODIALYSIS

Model Number	8888200001
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/27/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the red and blue adapters showed hairline cracks at the thread of the adapter when attaching a luer-lock syringe.This was discovered pre-operatively and was not used on a patient.
Additional Manufacturer Narrative
A device history review revealed no discrepancies that may have contributed to a complaint of this failure mode.All quality assurance testing performed during manufacturing was acceptable.The quality assurance review of the visual, physical and dimensional evaluation results indicated that the product met specification requirements.All dhr are reviewed for accuracy prior to product release.Three adapters attached to a syringe were received for analysis.Visual evaluation was performed and revealed that the adapters were broken.It presents signs of manipulation.Manufacturing performed 100% inspection for cracked adapters which would identify this issue in the catheter assembly.The reported condition has been confirmed.Based on the available information, it can be concluded that product was manufactured according to specifications; for this reason the adapters was more likely damaged due to manipulation and the most possible root cause can be considered as misuse.The instructions for use (ifu) were not followed causing adapter over tightening.No evidence was found to link this event to a manufacturing related cause.No trends or triggers have been found.No action is deemed necessary at this time.It must be noted that in-process controls are in place to prevent nonconforming product from leaving the manufacturing operations.This complaint will be used for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NA
• Common Device Name: KIT, REPAIR, CATHETER, HEMODIALYSIS
• Manufacturer (Section D): COVIDIEN MFG SOLUTIONS S.A.; edificio b20, calle #2; alajuela 20101
• MDR Report Key: 7285615
• Report Number: 3009211636-2018-00049
• Device Sequence Number: 1110029
• Product Code: NFK
• UDI-Device Identifier: 10884521056282
• UDI-Public: 10884521056282
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K092797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2018

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: 04/06/2021
• Device Model Number: 8888200001
• Device Catalogue Number: 8888200001
• Device Lot Number: 1612500126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2018
• Initial Date Received by Manufacturer: 01/23/2018
• Supplement Date Received by Manufacturer: 02/28/2018
• Initial Report FDA Received Date: 02/21/2018
• Supplement Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1