MAUDE Adverse Event Report: APPLIED MEDICAL RESOURCES CTF31, KII FIOS 11X150MM Z-THREAD, 6BX; GCJ

Model Number	CTF31
Medical Device Problem Codes	Bent (1059); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/22/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The event device was returned for evaluation.A follow-up report will be provided upon completion of investigation.In accordance with 21 cfr 803.56, if additional information is obtained which was not known or was not available when this report was submitted, then a supplemental report will be submitted to the fda.There is no report of serious injury or death associated with this event.Based on the description of the bent cannula during initial intake of the complaint, the event was not reported as it was unlikely to cause of contribute to death or serious injury.After the unit was received by applied medical, the event is now deemed reportable due to the fracturing of the cannula observed.
Event or Problem Description
Lap peritoneal dialysis catheter insertion - "[the surgeon] needed a longer trocar for a catheter insertion.He wanted long 8 but since we dont have he opted for an 11mmx150mm.When inserting the trocar the cannula bent in half.He pulled it out and called for an [competitor] to perform the case." additional information received via email from sales representative on (b)(6) 2017: was not sure if the 8mm incision extended to accommodate an 11mm trocar.During insertion, it was said that excessive force was not used according to the surgeon, but using standard more twist less push approach.Product was returned in the condition it was in after the case.Type of intervention: "[competitor] to perform the case." patient status: no patient injury.
Additional Manufacturer Narrative
The event unit was returned to applied medical for evaluation.Upon inspection, engineering confirmed that the cannula was bent.The likely root cause of the bent trocar is due to excessive force applied during insertion.Additional information was requested, however, none has been provided at this time.The probability and criticality of harm resulting from this failure mode have been evaluated and were found to be at an acceptable level.Applied medical will continue to monitor its vigilance system for trends and take appropriate actions, as necessary, to ensure the performance and safety of its products.

• Brand Name: CTF31, KII FIOS 11X150MM Z-THREAD, 6BX
• Common Device Name: GCJ
• Manufacturer (Section D): APPLIED MEDICAL RESOURCES; 22872 avenida empresa; rancho santa margarita CA 92688
• MDR Report Key: 6324344
• Report Number: 2027111-2017-01424
• Device Sequence Number: 10907044
• Product Code: GCJ
• UDI-Device Identifier: 00607915124823
• UDI-Public: (01)00607915124823(17)190705(30)01(10)1273941
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K041795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2017

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: Other
• Device Expiration Date: 07/05/2019
• Device Model Number: CTF31
• Device Catalogue Number: 101470704
• Device Lot Number: 1273941
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/12/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 05/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1