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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. DBD-TOTAL KNEE

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MEDLINE INDUSTRIES INC. DBD-TOTAL KNEE Back to Search Results
Catalog Number DYNJ907129B
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2021
Event Type  Injury  
Manufacturer Narrative

It was reported that an expired nacl irrigation bag was used during a total knee arthroscopy procedure. When the expired bag was identified, a new nacl irrigation bag was reportedly hung and the surgical site was irrigated with the solution. The reporting facility noted that "a good washout" was performed during the procedure. No additional medical intervention was performed and the patient did not require follow-up care in relation to the reported incident. No adverse patient impact was reported. Investigation into the reported incident included returned sample evaluation and analysis of production records. The incorrect entry of the nacl irrigation bag's expiration in the receiving system was determined to be the root cause. Due to the reported need for medical intervention, this medwatch is being filed. If additional relevant information become available a supplemental medwatch will be filed.

 
Event Description

It was reported that the nacl irrigation bag component within the total knee pack was expired.

 
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Type of DeviceDBD-TOTAL KNEE
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093 2753
Manufacturer Contact
nigel vilches
three lakes drive
northfield, IL 60093-2753
2249311458
MDR Report Key11567675
MDR Text Key242177585
Report Number1423395-2021-00016
Device Sequence Number1
Product Code OJH
Combination Product (Y/N)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 03/25/2021
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/25/2021
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue NumberDYNJ907129B
Device LOT Number20LBF040
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/10/2021
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/29/2021
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? No Answer Provided
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 03/25/2021 Patient Sequence Number: 1
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