MAUDE Adverse Event Report: SMITHS MEDICAL INTERNATIONAL, LTD. INTERVENOUS LINE JELCO; PIVC

Model Number 18 GAUGE

Device Problems Material Fragmentation (1261); Material Separation (1562)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Type  malfunction  

Event Description

Reported a smiths medical peripheral intravenous catheters (pivc)|jelco safety protectiv plus catheters 18g inserted in ed, the cannula broke and the patient required to go into theatre( hospital) to have the have the plastic sheath removed from his arm.No further information on patient condition.

Manufacturer Narrative

Retuned samples didn't show any anomaly.The needles were sharp, and the bevels were in compliance with the internal specification.Catheter security test: the value are in compliance with the internal specification.On the basis of the results achieved, there is no evidence that the unused unit did not comply with the internal specification.There was no fault found with the returned samples.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: INTERVENOUS LINE JELCO
• Type of Device: PIVC
• Manufacturer (Section D): SMITHS MEDICAL INTERNATIONAL, LTD.; boundary road; hythe, kent CT21 6JL; UK CT21 6JL
• MDR Report Key: 11484448
• MDR Text Key: 239775303
• Report Number: 3012307300-2021-02073
• Device Sequence Number: 1
• Product Code: HXK
• Combination Product (y/n): N
• 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: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 18 GAUGE
• Device Catalogue Number: 3065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention