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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY MITEK LLC US IRRIGATION TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
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DEPUY MITEK LLC US IRRIGATION TUBESET 24PK; SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE Back to Search Results
Model Number 284504
Device Problems Crack (1135); Fluid/Blood Leak (1250); Leak/Splash (1354)
Patient Problems Not Applicable (3189); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/06/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Additional narrative: udi: (b)(4).Incomplete the expiration date is unknown at this time.
 
Event Description
The instructor reported that the tube was torn, leaking serum during surgery.There was no damage to the patient, but there was a delay in surgery, the tube was replaced by another that worked perfectly.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary :according to the information provided, it was reported that during surgery, the instructor reported that the tube was torn, leaking serum.The complaint device is not being returned, therefore unavailable for a physical evaluation.However, a photo was provided.Upon visual inspection of the photo, observations revealed a section of tubing was damaged, it can see that it was cracked.The photo provide evidence of the failure reported into device, therefore the complaint reported can be confirmed.Hands on analysis should provide more evidence to be able to discern a root cause but the possible root cause for the reported failure can be attributed when it was not seated correctly on the rollers of the pump and the clamp is pressed down.However, this cannot be conclusive determined a manufacturing record evaluation was performed for the finished device [6346] number, and no non-conformances were identified.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.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: investigation summary: according to the information provided, it was reported that the instructor reported that the tube was torn, leaking serum during surgery.The complaint device was received and inspected.The tubing and connectors were observed for any gross visual defects that may cause a leak; also, there was fluid found within the tubing of the device.There was a large crack found in the tubing, which would cause the device to leak.Therefore, we can confirm this complaint due to there was damage to the device.The photo provided by the customer showed the same condition found during the physical analysis.A manufacturing record evaluation was performed for the finished device [6346] number, and no non-conformances were identified.It is possible that when it was not seated correctly on the rollers of the pump and the clamp is pressed down or damaged from handling; therefore, causing the tubing to become damaged.However, this cannot be conclusively determined.The ifu warns to avoid damage to tubing, make sure that the tubing is centered on the groove of the pump.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitkek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
 
Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by mitek or its employees that the report constitutes an admission that the device, mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H10 additional narrative: the actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
 
Event Description
It was reported by the affiliate in brazil that during an unknown surgery on an unknown date, it was observed that the irrigation tubeset device was torn and leaking serum.Another like device was used to complete the procedure without delay.There were no adverse patient consequences reported.No additional information was provided.
 
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Brand Name
IRRIGATION TUBESET 24PK
Type of Device
SURGICAL IRRIGATION TUBING SET, GENERAL-PURPOSE
Manufacturer (Section D)
DEPUY MITEK LLC US
325 paramount drive
raynham MA 02767
MDR Report Key10404703
MDR Text Key202871618
Report Number1221934-2020-02086
Device Sequence Number1
Product Code HRX
UDI-Device Identifier10886705017393
UDI-Public10886705017393
Combination Product (y/n)N
PMA/PMN Number
K951843
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 07/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number284504
Device Catalogue Number284504
Device Lot Number6346
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2021
Date Manufacturer Received07/05/2021
Patient Sequence Number1
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