MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC JELCO; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Lot Number 3768133

Device Problems Inadequacy of Device Shape and/or Size (1583); Dull, Blunt (2407)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 10/25/2019

Event Type  malfunction  

Event Description

Rn was placing an iv in patient's hand.When rn went to insert the tip of the needle, it was difficult to break through the skin.The needle was dull or the plastic catheter was too long and poking the patient instead of the needle.Rn stopped before causing patient further injury and removed iv from use.Patient has a small poke to her hand with minimal bleeding.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9375460
• MDR Text Key: 168001260
• Report Number: 9375460
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 3768133
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2019
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4380 DA