MAUDE Adverse Event Report: DEPUY MITEK 4503 USA IRRIGATION TUBE SETS PK/24 -SH; FMS TUBING

Catalog Number 284504

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/16/2014

Event Type  Injury  

Event Description

Approximately 20 min after the start of the operation, the pump is raced and tubing 284504 was quickly filled with an overpressure on the side of the patient.They cut off the pump.Then changed the tubing 284504.Pb returned.So they changed the column and thus pump fms.Pb is occurring again.They even changed tubing and intervention ended normally.Finally, loss of time and short relief and a priori no consequence for the patient, but difficult to see in a knee versus a shoulder.No error code.Loss of time, increasing the operating time.Pressure, but short, so a priori inconsequential, especially in a knee.Extension of the operation 45 minutes.The patient is well.See associated medwatch 1221934-2014-00493, 1221934-2014-00494.

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 of fill chamber filling up and a 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 corrective action.A pra was conducted and determined the patient risk to be low.It was noted that this lot was released before the corrective actions were implemented.A review into the depuy mitek complaints system revealed 3 similar and 1 dissimilar complaints for this lot of devices that were released to distribution.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.

• Brand Name: 4503 USA IRRIGATION TUBE SETS PK/24 -SH
• 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: siri belur ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 4244146
• MDR Text Key: 5016845
• Report Number: 1221934-2014-00492
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K951843
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/20/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 284504
• Device Lot Number: D407001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/20/2014
• Device Age: 6 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/20/2014
• Date Manufacturer Received: 10/20/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2014
• 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): Other