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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/03/2017
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
The tip of the wire broke when the surgeon was taking the product out of the packaging.Prior to patient contact.It was reported by the international customer that, during the removal of the product from the packaging, the tip of the wire broke.The customer has confirmed that this was prior to patient contact; accordingly, no adverse events were experienced by the patient.
Additional Manufacturer Narrative
Investigation - evaluation: a review of dimensional verification, device history record, quality control documents, manufacturing instructions, complaint history, and visual inspection was conducted on the returned device during the investigation.One wire guide was returned for evaluation.The distal end appeared to be missing due to the fact there was no curve present and the wire guide's shortened length.The measured coil diameter was found to be within specifications.The device history record was reviewed and confirmed that no nonconformance¿s were recorded.Since the c-tpns-9.0d-90-redo is supplied with set components, the device history record regarding the complaint device (scf-38-30-3) was reviewed.This nonconformance was identified as "weld, offset"; the non-conforming component was scrapped and not released as part of the lot.There were no other reported complaints for this lot number.The manufacturing documents in place at the time of manufacture were reviewed and it was found that the device aspect in question was visually inspected by quality control and no notable gaps in production or processing controls were noted.It is possible based on the provided information that the root cause of this event is related to customer use and/or handling.However, a definitive root cause cannot be determined.A risk assessment was performed to address this failure mode.No further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• Brand Name: REDO DOUBLE 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: 6834637
• Report Number: 1820334-2017-02621
• Device Sequence Number: 16160291
• Product Code: FOZ
• UDI-Device Identifier: 00827002294646
• UDI-Public: (01)00827002294646(17)180219(10)5611195
• Combination Product (Y/N): N
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2017

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-9.0D-90-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/14/2017
• Supplement Date Received by Manufacturer: 11/21/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 11/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1