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

Catalog Number 1180100777

Device Problem Insufficient Information (3190)

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

Event Type  malfunction  

Event Description

The customer reported that air bubbles are not easily discharged (new plunger structure).

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.

• Brand Name: CARDINALHEALTH
• Type of Device: 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: 19102796
• MDR Text Key: 340811282
• Report Number: 3005670221-2024-00052
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10192253034530
• UDI-Public: 0110192253034530
• 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
• Remedial Action: Recall
• 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: 04/13/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 1180100777
• Device Lot Number: 230204
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/04/2023
• 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