MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. JELCO IV CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L

Model Number 405311

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/16/2020

Event Type  Injury  

Event Description

Information was received indicating that upon removal of a smiths medical jelco iv catheter, a portion of the catheter was found missing.A series of radiographs were ordered and performed, indicating that the piece had migrated into the area of the scapula.The iv was reported to have been initially placed in the front cephalic vein and that the retained piece has not been removed.Complaints of pyrexia postoperatively has been noted with antibiotic and nsaid treatment has been prescribed.There have been no further reported adverse effects.

Manufacturer Narrative

Other text: one jelco iv catheter was returned for analysis.Upon visual examination of the sample, it was confirmed that the catheter broke at 6.85mm from the hub nose.It was found improbable that such type of damage may have been originated during the manufacturing process.There is considerable parameters are 100 % controlled during the different manufacturing phases.Based on the evidence, the root cause was found due to one of the two user errors: needle reinsertion; use of a lancet near the catheter.

• Brand Name: JELCO IV CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM L
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; 1500 eureka park; ashford, kent TN25 4BF; UK TN25 4BF
• MDR Report Key: 10338873
• MDR Text Key: 200815462
• Report Number: 3012307300-2020-07653
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 15019315118340
• UDI-Public: 15019315118340
• Combination Product (y/n): N
• PMA/PMN Number: K990236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/14/2022
• Device Model Number: 405311
• Device Catalogue Number: 405311
• Device Lot Number: 3870897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention