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

Lot Number 3757184, 3752067

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2019

Event Type  malfunction  

Event Description

22g peripheral ivs not working properly.There should be a flash of blood in the iv chamber when the rn or iv tech accesses the vein, however this flash is not occurring, which causes the rn/tech to not know whether have actually accessed the vein.It seems isolated to two lot numbers primarily, so there will be an internal recall of these specific lots.This primarily impacts the infusion therapy center (itc) and the iv/tx service as we place the majority of 22g pivs, however 22g piv of this brand are also stocked in our ors and radiology areas, so we will ensure these areas are aware of the issue.

• Brand Name: JELCO
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 201 west queen st.; southington CT 06489
• MDR Report Key: 8636002
• MDR Text Key: 145974937
• Report Number: 8636002
• 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: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 3757184, 3752067
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/02/2019
• Event Location: Other
• Date Report to Manufacturer: 05/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1