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

Catalog Number 16-SN05C2705P

Device Problem Insufficient Information (3190)

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

Event Date 09/24/2021

Event Type  malfunction  

Manufacturer Narrative

The returned samples was requested but hasn't been received till now, the lot number of this event was received, the dhr of this lot was reviewed without any issuses.The retained samples of the lot was tested and the samples met the specification.The root cause can't detected currrently, no action will be taken currently, a supplemental report will be submitted if further information received.

Event Description

The customer reported that the plunger is difficult to pull out; the cannula isn't in the middle position of needle hub; the cannula broke before injection; the cannula break when injection operated.The cannula seems fragile.

• 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: 19102922
• MDR Text Key: 340807637
• Report Number: 3005670221-2024-00084
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10612479231723
• UDI-Public: (01)10612479231723
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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

• Date FDA Received: 04/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 16-SN05C2705P
• Device Lot Number: CJCA03-01
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/01/2021
• 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