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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM

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JELCO CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM Back to Search Results
Model Number 305706
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Three used and four unused smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheters were returned for analysis. The used samples were visually examined for potential nonconformances. The locked-out needle guard assemblies displayed normal flash in the flashback chamber with no evidence of bent or broken cannula. After the device was reassembled and gently returned to unlocked position, magnified examination of the device tip displayed no evidence of cannula tip irregularities or catheter bevel high trim. All three used catheter assemblies displayed evidence of bevel tip damage indicating premature advancement of the catheter during use. Magnified examination of the catheter tubes noted punctures at approximately mid-tube length in two of the three catheter assemblies, displaying the "j" shape profile of the introducer needle. This "j" shape incision is consistent with a catheter wall penetration by the cannula as a result of a redirect during insertion and not the result of a manufacturing nonconformance. The four unused, unopened sister samples were visually evaluated for potential nonconformances and tested for force to advance and force to lock. The unused sister samples were found to be acceptable. Examination of the photos of the used catheter assemblies against smiths medical technical report for investigation into causes of catheter shear failure modes suggests the reinsertion of the needle into the catheter sheared/punctured the catheter tubing. Based on device analysis, the reported event was determined to be due to a variation in insertion technique. Based on the evidence, the complaint was not confirmed, and the problem source of the reported event was noted to be user interface.
 
Event Description
Information was received indicating that a smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv catheter, broke/bent upon insertion. No patient consequences were reported. No adverse effects were reported.
 
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Brand NameJELCO
Type of DeviceCATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
MDR Report Key12481011
MDR Text Key271682153
Report Number3012307300-2021-09405
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K990236
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial
Report Date 09/16/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/16/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Model Number305706
Device Catalogue Number305706
Device Lot Number4062864
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/06/2021
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received09/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/09/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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