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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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SMITHS MEDICAL ASD, INC. JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number 326610
Device Problems Break (1069); Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2021
Event Type  Injury  
Manufacturer Narrative
One 20g viavalve catheter assembly, without sheath, needle guard assembly and blister packaging, was returned for analysis. Initial visual examination of the sample confirmed that there was no catheter tube present. Magnified examination of the sample also displayed evidence of damage to the catheter hub nose od, consistent with scissors inadvertently cutting against the hub. Additionally, visual examination of the seal component displayed no evidence of actuation. The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution. No issues were identified that would have impacted this event.
 
Event Description
It was reported that a when the customer removed saline lock of a smiths medical catheter no cathlon was noted on the end. Patient was examined via x-ray in effort to locate catheter piece. No piece was found and no further treatment was needed.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer (Section G)
SMITHS MEDICAL ASD, INC.
10 bowman dr.
keene NH 03431
Manufacturer Contact
david halverson
6000 nathan lane north
minneapolis, MN 55442
MDR Report Key11817266
MDR Text Key250368471
Report Number3012307300-2021-04293
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K160235
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation
Type of Report Initial
Report Date 05/13/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number326610
Device Catalogue Number326610
Device Lot Number3995085
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2021
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/12/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/18/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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