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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP

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MEDLINE INDUSTRIES LP IV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP Back to Search Results
Catalog Number DYNDTN1603
Device Problem Crack (1135)
Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/27/2022
Event Type  Injury  
Event Description
It was reported that on (b)(6) 2022 during a procedure the iv tubing line cracked at the connection port resulting in the patient not receiving the required medication to effectively keep them asleep. According to the facility the patient required anesthesia intervention.
 
Manufacturer Narrative
It was reported that on (b)(6) 2022 during a procedure the iv tubing line cracked at the connection port resulting in the patient not receiving the required medication to effectively keep them asleep. Per the facility new tubing was required and the medication line was changed. According to the facility the patient required anesthesia intervention, however, the patient's recovery was not impacted. Photos have been returned that show the customer reported issue to be confirmed however a definitive root cause has not been established. No additional information is available at this time. Due to the reported incident and in an abundance of caution, this medwatch is being filed. If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
 
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Type of DeviceIV EXT SET,60",2.0ML, M/F LUERLOCK,CLAMP
Manufacturer (Section D)
MEDLINE INDUSTRIES LP
three lakes drive
northfield IL 60093
Manufacturer Contact
justin herrmann
three lakes drive
northfield, IL 60093
MDR Report Key15188330
MDR Text Key297496363
Report Number1417592-2022-00134
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeBD
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation
Type of Report Initial
Report Date 08/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/08/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberDYNDTN1603
Was Device Available for Evaluation? No
Date Manufacturer Received07/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/08/2022 Patient Sequence Number: 1
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