MAUDE Adverse Event Report: DEPUY MITEK MITEK FMS USA IRRIGATION TUBE SET; FMS TUBING

Catalog Number 284504

Device Problem Unknown (for use when the device problem is not known) (2204)

Patient Problem Surgical procedure, delayed (2565)

Event Date 04/17/2014

Event Type  Injury  

Event Description

The sales rep reported the during a hip surgery that two fill chambers of the customer's irrigation tubing sets filled up right away when the tube sets were being setup.The sales rep reported that the luer lock was securely fastened and that the customer has experience with these products.The 3rd set of tubing was cut where the tubing goes around the inflow wheel and when attached began to spray everywhere including the sterile field, which needed to be redone.The sales rep reported the surgeon completed the procedure with a fourth set of tubing with a different lot number.There were no patient consequences but that the procedure was delayed over an hour.The customer discarded the 1st two sets of tubing but is returning the third for evaluation.Additional information: the sales rep was contacted on (b)(6) 2014 to confirm if the patient was under anesthesia at the time of the event and he confirmed that yes the patient was under anesthesia from the very beginning when the 1st tube set failed.This increased the time the patient was under for over an hour.See associated medwatch #'s 1221934-2014-00177 and 1221934-2014-00179.

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy mitek however it is not known if it will be received within the 30 day reporting requirement, therefore, depuy mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.

Manufacturer Narrative

The complaint tubing is not being returned and therefore is not available for a physical evaluation.However, a few unused samples of this tube set from different lots were tested to replicate this failure and a potential manufacturing error was identified.Supplier identified tool wear on 3 out of 8 molds which created flash leading to increased torque needed to close the luer lock.If the luer lock is not completely tightened, an air leak occurs causing the fill chamber to overfill.The tooling was fixed by the supplier under a capa.A pra was conducted and determined the patient risk to be low.A batch record review has been conducted and the results indicate that this batch of product was processed without incident as related the reported problem, and therefore there is no internally assignable cause for the reported problem.Further, a review into the depuy mitek complaints system revealed 2 dissimilar complaints for this lot of devices that were released to distribution.This failure has been mitigated successfully through the capa and no new complaints have been reported for the fill chamber issues.Depuy mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

The sales rep reported the during a hip surgery that two fill chambers of the customer's irrigation tubing sets filled up right away when the tube sets were being setup.The sales rep reported that the luer lock was securely fastened and that the customer has experience with these products.The 3rd set of tubing was cut where the tubing goes around the inflow wheel and when attached began to spray everywhere including the sterile field, which needed to be redone.The sales rep reported the surgeon completed the procedure with a fourth set of tubing with a different lot number.There were no patient consequences but that the procedure was delayed over an hour.The customer discarded the 1st two sets of tubing but is returning the third for evaluation.Additional information: the sales rep was contacted on (b)(6) 2014 to confirm if the patient was under anesthesia at the time of the event and he confirmed that yes the patient was under anesthesia from the very beginning when the 1st tube set failed.This increased the time the patient was under for over an hour.See associated medwatch #'s 1221934-2014-00177 and 1221934-2014-00179.

• Brand Name: MITEK FMS USA IRRIGATION TUBE SET
• Type of Device: FMS TUBING
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: david primmerman ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 3808606
• MDR Text Key: 16452579
• Report Number: 1221934-2014-00178
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 284504
• Device Lot Number: D401618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 04/17/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/17/2014
• Date Manufacturer Received: 04/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention