MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. MCKESSON; INSULIN SYRINGE

Catalog Number 102-SN05C31516P

Device Problem Insufficient Information (3190)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/20/2023

Event Type  malfunction  

Manufacturer Narrative

The returned samples and retained samples were inspected, all of them met the specification, the dhr of this lot was reviewed without any issuses.The root cause can't detected currrently, no action will be taken.This issue will be monitored.A supplemental report will be submitted if further information received.

Event Description

Syringe leakage needle is blunt, patients complained of painful injections.1ml and 0.5ml packages are purple, not easy to distinguish between them.

• Brand Name: MCKESSON
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd; zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer (Section G): JIANGSU CAINA MEDICAL CO., LTD.; no 23, huanxi rd; zhutang town; jiangyin, jiangsu 21441 5; CH 214415
• Manufacturer Contact: camel zhou ; no 23, huanxi rd; zhutang town; jiangyin, jiangsu 21441-5 ; CH 214415
• MDR Report Key: 19102880
• MDR Text Key: 340807904
• Report Number: 3005670221-2024-00046
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 02061247918773
• UDI-Public: 01020612479187737
• Combination Product (y/n): N
• PMA/PMN Number: K151949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/14/2024

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 Catalogue Number: 102-SN05C31516P
• Device Lot Number: CJCA10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/24/2023
• Initial Date FDA Received: 04/14/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other