MAUDE Adverse Event Report: JIANGSU CAINA MEDICAL CO., LTD. CARDINAL; TUBERCULIN SYRINGE

Catalog Number	8881501160
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that the needles are smaller than before and do not fit the plunger.They provided two photos and stated that the orange needle hub is the unit they recently received, but they say the needle size is different, and is much smaller - like a 27g instead of a 25g.The color of the needle hub has also changed and they have concerns over the plunger and stated that the needle won't stay on.Additional information received on 13mar2024 clarified that the hub won't stay on the syringe while in use.The color of the hub has changed (from red to orange, orange typically means a 27g needle, instead of the red 25g needle).The plunger is changed (from standard to zero-waste, which makes it difficult to read the volume indicator lines).These changes have made the staff very unhappy.
Additional 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.

• Brand Name: CARDINAL
• Common Device Name: TUBERCULIN 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: 19244510
• Report Number: 3005670221-2024-00136
• Device Sequence Number: 15190828
• Product Code: FMF
• UDI-Device Identifier: 50192253035290
• UDI-Public: 0150192253035290
• Combination Product (Y/N): N
• PMA/510(K) Number: K141359
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/04/2024

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: 8881501160
• Device Lot Number: 230701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown