MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON BRANDS; SYRINGE, LL 20CC

Catalog Number 16-S20C

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Eye Injury (1845)

Event Date 03/11/2022

Event Type  malfunction  

Event Description

It was reported that an employee was sprayed in the eyes with a chemotherapy drug, carboplatin causing chemical abrasions to the right eye.The 20ml syringe cracked during injection of the drug into a bag.Antibiotic drops and an ophthalmologist follow up were required.

• Brand Name: MCKESSON BRANDS
• Type of Device: SYRINGE, LL 20CC
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no. 23 huanxi rd; zhutang town, jiangyin city ; CH
• MDR Report Key: 14013203
• MDR Text Key: 288596635
• Report Number: 1451040-2022-00012
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2022,04/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 16-S20C
• Device Lot Number: CJCA09-03
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/05/2022
• Distributor Facility Aware Date: 03/11/2022
• Device Age: 6 MO
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 04/05/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other