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

Model Number	405311
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/16/2020
Type of Reportable Event	Serious Injury
Event or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 3012307300-2020-07653
• Device Sequence Number: 3749180
• Product Code: FOZ
• UDI-Device Identifier: 15019315118340
• UDI-Public: 15019315118340
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K990236
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/03/2020
• Supplement Date Received by Manufacturer: 09/10/2020
• Initial Report FDA Received Date: 07/29/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention