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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CVC BUNDLE KIT
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MEDLINE INDUSTRIES INC.; CVC BUNDLE KIT Back to Search Results
Catalog Number ECVC6225A
Device Problem Crack (1135)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/04/2021
Event Type  malfunction  
Manufacturer Narrative
Medwatch report number (b)(4), filed by (b)(6) hospital reported the needle used to access the vessel for a triple lumen insertion (from a cardiac cath kit) had a cracked head.This resulted in the patient having multiple sticks prior to the problem being identified.Additional information received by risk manager, (b)(6) hospital in regards to this incident.Reporter states, "(b)(6) year-old female with a history of diabetes (dm), hypertension (htn), hepatitis, esophageal varices, and asystole arrest x 1.Needle used to access vessel for triple lumen insertion had a cracked head.This prevented negative pressure from being applied when attempting to access vessel.Patient stuck multiple times before the problem was identified." reporter states, "device was saved and another one was obtained." reporter states, "no known harm to patient at this time." reporter states, "unknown if sample is available for return and evaluation." reporter was unable to provide any further details related to this incident.Due to the reported incident, medical intervention 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.
 
Event Description
It was reported, the needle used to access the vessel for a triple lumen insertion (from a cardiac cath kit) had a cracked head.This resulted in the patient having multiple sticks prior to the problem being identified.
 
Manufacturer Narrative
Changed/additional information added.D9 device available for evaluation -n/a.G6 type of report - follow-up.H2 if follow-up what type? additional information.H3 device evaluated by manufacturer - n/a.H6 type of investigation- 11, 3331.H5 investigation conclusion - zcd00006/unconfirmed defect, 0003/sample required to determine cause.H10 investigation report reads as follows: (b)(6) 2021 08:53:07 cst (ncoan)."a review of the production records for ecvc6225a lot number 2021011350 did not find a nonconformance noted by production or quality control personnel during the first article, in process, or case packaging inspections.Since a complaint sample was unavailable, 5ea ect1825 needles from the complaint lot were removed from inventory for evaluation.Each sample was connected to a syringe and functioned as expected.Examination of the samples under magnification identified no cracks in the hub of the needles.The vendor was also notified of the report.The vendor confirmed no similar reports associated with this lot have been received and an investigation would be performed.However, the results of the vendor investigation have not been received at this time.Should a response be received in the future, it will be added to the complaint file.Although a root cause could not be positively identified, it should be noted that during a previous investigation the manufacturer stated the ect1825 is not designed to have the needle component inserted deeply into a patient and then severely manipulated using a luer slip syringe for additional leverage.Under those conditions, an excessive amount of force is exerted on the outer rim of the luer taper geometry, which could cause a luer hub material failure.".
 
Event Description
It was reported, the needle used to access the vessel for a triple lumen insertion (from a cardiac cath kit) had a cracked head.This resulted in the patient having multiple sticks prior to the problem being identified.
 
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Type of Device
CVC BUNDLE KIT
Manufacturer (Section D)
MEDLINE INDUSTRIES INC.
three lakes drive
northfield IL 60093
MDR Report Key11623417
MDR Text Key245496654
Report Number1038445-2021-00002
Device Sequence Number1
Product Code OES
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,other,use
Type of Report Initial,Followup
Report Date 05/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberECVC6225A
Device Lot Number2021011350
Was Device Available for Evaluation? No
Date Manufacturer Received03/24/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age46 YR
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