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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OAKDALE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET; WARMER, THERMAL, INFUSION FLUID

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OAKDALE LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET; WARMER, THERMAL, INFUSION FLUID Back to Search Results
Model Number L-70
Device Problem Leak/Splash (1354)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/01/2023
Event Type  malfunction  
Event Description
It was reported that while infusing medical fluid into the patient through the product, leakage from the connector was observed.No patient injury was reported.
 
Manufacturer Narrative
Month and year of event have been provided, day is unknown.Lot number and expiration date is unknown, no product information has been provided to date.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
 
Manufacturer Narrative
Other text: h6 health impact and conclusion codes: updated.Device evaluation: one device and two photos were returned for investigation.Visual inspection showed the proximal end female luer connecter to be cracked.During functional testing, the reported failure mode, leak, was confirmed.Based on the sample returned by the customer it was not possible to replicate the failure or confirmed as manufacturing process caused.After reviewing the mitigations that are performed during the manufacturing process to detect leak, the root cause is that the female luer connector became damaged after the product left manufacturing facilities.No lot number was provided therefor no device history review (dhr) could be completed.No corrective actions taken., corrected data: d3.
 
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Brand Name
LEVEL 1 LOW FLOW HOTLINE DISPOSABLE INJECTION SET
Type of Device
WARMER, THERMAL, INFUSION FLUID
Manufacturer (Section D)
OAKDALE
3350 granada ave n
oakdale MN 55128
Manufacturer (Section G)
NULL
6000 nathan lane north
minneapolis MN 55442
Manufacturer Contact
jim vegel
6000 nathan lane north
2-12-12, kitanagase-omotemachi
minneapolis, MN 55442
MDR Report Key16534955
MDR Text Key311209498
Report Number3012307300-2023-02344
Device Sequence Number1
Product Code LGZ
UDI-Device Identifier30695085407007
UDI-Public30695085407007
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K911383
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 05/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberL-70
Device Catalogue NumberL-70
Was Device Available for Evaluation? No
Date Returned to Manufacturer02/24/2023
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/20/2023
Initial Date FDA Received03/13/2023
Supplement Dates Manufacturer Received05/12/2023
Supplement Dates FDA Received05/31/2023
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
Patient Sequence Number1
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