MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.
Event or Problem Description
International customer reported that a patient was scheduled for a nephrostomy procedure.The customer reports that the tip of the redo single lumen tpn catheter broke.The event occurred during device examination prior to use on the patient.A replacement catheter was obtained to complete the procedure there are no reports of adverse patient consequences related to this event.The device is reportedly available for evaluation; however it has not been received by the manufacturer as of the date of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the dimensional verification, complaint history, device history record, manufacturing instructions, quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.One.035" wire guide from the reported redo single lumen tpn catheter set was returned with a broken tip.The visual inspection of the returned device confirmed that the flat wire width, thickness, length, and wire guide diameter were all within manufacturing specification.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed one nonconforming event related to this failure mode.The affected product was discarded.It should be noted there were no other reported complaints for this lot number.A document review was performed on the wire guide in the redo single lumen tpn catheter set for the manufacturing specifications, manufacturing instructions, and quality control instructions.There were no gaps found in production or processing controls of the wire guide.Based on the information provided and the results of our investigation, a definitive root cause could not be determined.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6777538
• Report Number: 1820334-2017-02193
• Device Sequence Number: 220966
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)200316(10)7649771
• Combination Product (Y/N): N
• Initial Reporter Country: SE
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2017

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 Model Number: N/A
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/02/2017
• Supplement Date Received by Manufacturer: 11/07/2017
• Initial Report FDA Received Date: 08/09/2017
• Supplement Report FDA Received Date: 11/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1