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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO IV SAFETY CATHETER

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SMITHS MEDICAL ASD, INC. JELCO IV SAFETY CATHETER Back to Search Results
Lot Number 3749048
Device Problem Fluid Leak (1250)
Patient Problem Hemostasis (1895)
Event Type  Injury  
Manufacturer Narrative
Thirteen jelco safety viavalve catheters were returned for analysis. The returned samples were visually evaluated and tested for seal leakage and for seal actuation per procedure and were found to be acceptable. As a result, the reported event could not be confirmed as a manufacturing-related nonconformance. In-process and at post sterile, product is evaluated for seal leakage and is inspected by certified operators using statistically valid sampling plans at defined intervals. If any nonconformances are found in process, the product is isolated, non-conformed and immediate action is taken to perform corrections. Sampling plans are based on random sampling selection and are designed to provide a high level of assurance that the true fraction defective is less than or equal to the established aql level for each quality characteristic. No correction or corrective actions will be conducted by the manufacturing facility at this time as there was no fault found.
 
Event Description
Information was received that the jelco safety viavalve catheter malfunctioned. It was reported that after puncturing the product to the patient and removing the needle, the collected blood leaked from it because the hemostasis valve did not work. A hemostasis operation was performed to stop any further bleeding.
 
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Brand NameJELCO
Type of DeviceIV SAFETY CATHETER
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
201 west queen st.
southington CT 06489
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key10783071
MDR Text Key214513991
Report Number3012307300-2020-10964
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial
Report Date 11/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/04/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/18/2021
Device Lot Number3749048
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/16/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/29/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/04/2020 Patient Sequence Number: 1
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