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	Material Rupture (1546)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/12/2017
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 pediatric patient received a redo single lumen total parenteral nutrition (tpn) catheter on an unspecified date.The patient was undergoing parenteral nutrition for an indication related to digestive hemorrhages.The patient's mother contacted the pediatric auxiliary on (b)(6) 2017 reporting that the catheter was 'disassociated.' the nurse examined the device and found a rupture of the catheter near the clamp, however the plaster was still clean, sealed and the protective loop was still in place.The nurse reports this means that the catheter wasn't pulled.The child was reported as calm and not in pain.There is no report of any intervention to address this event as of the date of this report.The device is not available for examination.Additional information was requested; no further information was received.A follow-up report will be submitted upon receipt of any additional information.
Additional Manufacturer Narrative
Investigation ¿ evaluation: one complaint device was returned for investigation.The hub was not returned.Visual inspection of the returned device was performed.The catheter measured 26 cm in length.The flare measured 3 mm.A review of documentation, manufacturing instructions, specifications and quality control data was conducted during the investigation.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.The redo single lumen tpn catheter set is shipped with instructions for use (ifu), which clearly state the proper warnings, precautions, and instructions for use with each device.Specifically; ¿extreme caution must be used in placement and monitoring of catheters.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.If lumen flow is impeded, do not force injection or withdrawal of fluids.Notify attending physician immediately.Catheter size should be as small as the use will allow." based on the provided information, inspection of returned product, and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will notify the appropriate personnel and continue to monitor for similar complaints.

• 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: 6657231
• Report Number: 1820334-2017-01493
• Device Sequence Number: 19120068
• Product Code: FOZ
• UDI-Device Identifier: 00827002079038
• UDI-Public: (01)00827002079038(17)191027(10)7327090
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/25/2017

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-4.0-65-REDO
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/22/2017
• Supplement Date Received by Manufacturer: 08/08/2017
• Initial Report FDA Received Date: 06/21/2017
• Supplement Report FDA Received Date: 08/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1