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 Unknown (for use when the patient's condition is not known) (2202)

Event Date 07/30/2014

Event Type  Injury  

Event Description

The tubing was used in a previous case, and when the regular scout nurse (junior staff) went to replace the tubing for the next case, a non regular but senior staff member over-ruled her, and insisted that it was a reusable item (as per a previous product code).This single use only tubing was, therefore, re-used on patient (b)(6), and again for another case, patient (b)(6).The regular nursing staff received in-service training at the time of the product changeover and regularly trained since, including written and oral communication.It is unknown if there has been an adverse effect on patients as yet, surgeon who was also informed of the incident on (b)(6) 2014, is to contact the patients and follow-up as appropriate.A formal incident report had been raised by the hospital and rep has discussed the issue with the director of clinical services.

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 device is not being returned, therefore is unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.Irrigation tubing product code 284504 can be used for the day providing it is used with patient outflow tubing containing a one way pillow valve.Reports are the customer used patient outflow tubing that did not contain a one way pillow valve.Our ifu states that the one day set may be used for multiple procedures during the same surgical day provided that proper set-up and tube changing procedures are followed in order to preserve sterility.The set-up procedure can be found in ifu-109076-kim starting on page 17.Page 19 discusses the setup of intermediary irrigation tube sets with one-way check valves in order to allow multiple uses of the one day set (in this case, tube set (b)(4)).Without the check valve tubing is intended to be single use only.Therefore the root cause is determined to be the user not following ifu instructions during setup of tube sets.At this point in time, no corrective action is required and no further action is warranted.However, depuy synthes 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.Should any new information be received in regards to the patient¿s condition, this file will be reopened and updated at that time and a follow-up report will be filed.

Event Description

The tubing was used in a previous case, and when the regular scout nurse (junior staff) went to replace the tubing for the next case, a non regular but senior staff member over-ruled her, and insisted that it was a reusable item (as per a previous product code).This single use only tubing was therefore re-used on patient sq, and again for another case, patient (b)(6).The regular nursing staff received inservice training at the time of the product changeover and regularly trained since, including written and oral communication.It is unknown if there has been an adverse effect on patients as yet, surgeon who was also informed of the incident on (b)(6) 2014, is to contact the patients and follow-up as appropriate.A formal incident report had been raised by the hospital and rep has discussed the issue with the director of clinical services.The following information was received from our affiliate via email on september 23, 2014; the proper set-up of the pump and tube sets was followed for the arthroscopic shoulder surgery.However there was no one way valve used and the inflow tubing was reused instead of being discarded as it should have been.Lot numbers of the tube set are unavailable.There is no update on the patient's status.The surgeon was to inform the patient and have blood tests done, routine pre-op blood tests were normal.

• 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: 4097041
• MDR Text Key: 22138326
• Report Number: 1221934-2014-00402
• Device Sequence Number: 1
• Product Code: HRX
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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,Followup
• Report Date: 08/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 284504
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/27/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2014
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other