MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. JELCO® PROTECTIV® SAFETY I.V. CATHETERS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number 306039

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Necrosis (1971); Local Reaction (2035)

Event Type  Injury  

Event Description

Information was received that redness around the needle was observed on a patient while using a smiths medical catheter.This was observed 5 to 6 hours after the start of infusion.This included an early necrosis for one patient.The patient was subcutaneously injected into the thigh, and disinfection of the skin before puncture was done with dakin.A dermatologist had described an erythema that is spreading.

Manufacturer Narrative

One catheter was returned for evaluation.Visual inspection of the device found it to be in good physical condition.The sterilization records of the complained lot number were reviewed, and all the parameters comply with the specified requirements.Pivcs manufactured in latina plant are sterilized by ethylene oxide and the sterilization cycle is validated according to uni en iso 11135-1 requirements.Moreover the pivcs are biocompatible according to iso 10993-1 requirements and endotoxin free.On the basis of the results achieved, there is no evidence that the product did not comply with the internal specification.The reported customer complaint has not been confirmed.

• Brand Name: JELCO® PROTECTIV® SAFETY I.V. CATHETERS
• 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: 8510857
• MDR Text Key: 141810052
• Report Number: 3012307300-2019-01975
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 10/19/2021
• Device Catalogue Number: 306039
• Device Lot Number: 3708028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2019
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/12/2019
• Supplement Dates Manufacturer Received: 06/13/2019
• Supplement Dates FDA Received: 07/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention