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

Catalog Number 8341

Device Problem Difficult to Advance (2920)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that during use of this peripheral intravenous catheters, there was no back flow of blood after cannulation.The reported information indicated that multiple pricks were required for successful cannulation.No further adverse patient effects were reported.

Manufacturer Narrative

After review of this complaint, it was initially assessed as malfunction reportable.It's stated having had difficulty performing venipuncture due to a compromised insertion mechanism the risks of perforation of vessel, pain, phlebitis, and hematoma does not meet the definition of a reportable serious injury as there was no reported permanent impairment of a body function, or no intervention was required to preclude serious impairment.The reported no back flow of blood and multiple venipuncture attempts were required does not indicate that this would likely cause or contribute to a death or serious injury if the malfunction were to recur.This complaint was reported in error.

• Brand Name: JELCO SERIVA¿ SIDE PORT IV CATHETER
• 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: 7541572
• MDR Text Key: 109240812
• Report Number: 3012307300-2018-01974
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 8341
• Device Lot Number: 3178617G
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/24/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 10/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1