MAUDE Adverse Event Report: CARDINAL HEALTH CARDINAL HEALTH; 27 GAUGE NEEDLE 1 INCH

Catalog Number N3602710

Device Problems Nonstandard Device (1420); Device Disinfection Or Sterilization Issue (2909)

Patient Problem Cellulitis (1768)

Event Date 07/11/2017

Event Type  Injury  

Event Description

Cardinal health which i believe is now owned by (b)(6) sent us an urgent product recall for 27 gauge 1 inch needles related to them not having record of sterilization.We gave 2 immunizations to a child who then developed cellulitis at the injection site later that night he went to the emergency room (er) for treatment.

• Brand Name: CARDINAL HEALTH
• Type of Device: 27 GAUGE NEEDLE 1 INCH
• Manufacturer (Section D): CARDINAL HEALTH; waukegan IL 60085 6728
• MDR Report Key: 6763421
• MDR Text Key: 81806685
• Report Number: MW5071344
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/01/2017

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: Health Professional
• Device Catalogue Number: N3602710
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/01/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 4 YR