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

Model Number	326510
Medical Device Problem Codes	Break (1069); Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/11/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
An empty plastic bag, with no device or components included, was returned for analysis.No investigation or root cause analysis could be conducted given that no complaint sample was returned.As reported, the reported event could not be verified and/or confirmed with confidence, therefore, no further correction, corrective or preventive actions will be conducted by the manufacturing facility at this time.Complaint information will continue to be monitored.Smiths medical regularly reviews and analyzes post-market data for new information or adverse trends, implementing corrections, taking corrective and preventative actions accordingly.
Event or Problem Description
It was reported that in the emergency room a nurse inserted 18g iv into patient's left antecubital fossa.Iv infiltrated.Labs drawn off it.While trying to remove iv catheter, catheter got stuck.Medic at the bedside started to pull catheter out.Part of catheter tip appears to have sheared off into the vein.Catheter measured and approximately 6mm of catheter is believed to be left inside of patients arm.Surgeon successfully removed approximately 0.3cm of retained catheter.No complications and patient was discharged the next day.
Additional Manufacturer Narrative
Other, other text: returned device was received for evaluation.During the evaluation of the device the customer reported condition was not confirmed, an empty plastic bag, with no device or components included, was returned for analysis.No investigation or root cause analysis could be conducted given that no complaint sample was returned.No fault found.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.

• Brand Name: JELCO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 10 bowman dr.; keene NH 03431
• MDR Report Key: 11127664
• Report Number: 3012307300-2021-00106
• Device Sequence Number: 676522
• Product Code: FOZ
• UDI-Device Identifier: 15019517078411
• UDI-Public: 15019517078411
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K160235
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/28/2022
• Device Model Number: 326510
• Device Catalogue Number: 326510
• Device Lot Number: 3980574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/08/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 01/06/2021
• Supplement Report FDA Received Date: 01/28/2021
• 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: Required Intervention
• Patient Age: 50 YR
• Patient Weight: 44