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

Catalog Number 16-S10C

Device Problem Insufficient Information (3190)

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

Event Date 06/21/2022

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

The customer reported that the barrel broke and drug leakage when using.

• Brand Name: MCKESSON
• Type of Device: DISPOSABLE 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: 19102911
• MDR Text Key: 340802821
• Report Number: 3005670221-2024-00103
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479206882
• UDI-Public: (01)10612479206882
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113091
• 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

• Date FDA Received: 04/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 16-S10C
• Device Lot Number: CJCA12-06/CJCA10-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other