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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITHS MEDICAL ASD; INC. JELCO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
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SMITHS MEDICAL ASD; INC. JELCO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Catalog Number 4038-AI
Device Problem Material Fragmentation (1261)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/28/2020
Event Type  Injury  
Event Description
Information was received indicating that upon removal of a smiths medical jelco iv catheter, the cannula broke off in the patient.The patient was reported to be taken to surgery for successful removal of the retained piece.The patient recovered and was discharged.There were no further reported adverse effects.
 
Manufacturer Narrative
One catheter was returned for evaluation.Visual inspection of the device found it to be in good physical condition; needle noted to be sharp and bevel did not show any anomaly.Investigation found no evidence units did not comply with internal specifications.The reported customer complaint was unable to be confirmed.
 
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Brand Name
JELCO IV CATHETER
Type of Device
CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
Manufacturer (Section D)
SMITHS MEDICAL ASD; INC.
6000 nathan lane n
minneapolis,, mn
MDR Report Key9908301
MDR Text Key185915450
Report Number3012307300-2020-02640
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,user faci
Type of Report Initial,Followup
Report Date 08/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/31/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/26/2023
Device Catalogue Number4038-AI
Device Lot Number3738126
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/25/2020
Date Manufacturer Received07/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age38 YR
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