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

Catalog Number 18520

Device Problem Blocked Connection (2888)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/12/2019

Event Type  malfunction  

Manufacturer Narrative

One smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter was returned for analysis.During analysis, it was noted that it is improbable that such type of damage may have been originated during the manufacturing process, considering that critical parameters are 100 % controlled during the different manufacturing phases.It was also noted that when a cannula is broken in two parts a possible cause could be an improper use of the device.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 while in use of a smiths medical peripheral intravenous catheters (pivc)|jelco conventional jelco iv catheter, the customer felt resistance through it, so they removed the cannula from the patient.No patient consequences were reported.No adverse effects were reported.

• Brand Name: JELCO
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 12468884
• MDR Text Key: 271311939
• Report Number: 3012307300-2021-09348
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 18520
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1