MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-SLIP RP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED

Model Number 8881520673

Device Problem Break (1069)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

The customer reported that upon completion of treatment, the tip of the syringe broke off in the patient's hd catheter.The clinician, educator and nephrologist are aware.The tip was finally removed with forceps and no damage was seen to the catheter hub.Per additional information received, there was no medical intervention required.

Manufacturer Narrative

An investigation is currently underway.Upon completion, the results will be forwarded.

Manufacturer Narrative

A decontaminated sample was received at the plant for the investigation.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Upon a visual evaluation of the sample, the reported issue was confirmed; the luer tip of the syringe barrel broke off near the base of the syringe barrel face.

• Brand Name: MONOJCT 20ML SYR L-SLIP RP
• Type of Device: APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16845101
• MDR Text Key: 314367389
• Report Number: 1915484-2023-01314
• Device Sequence Number: 1
• Product Code: GCX
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2023

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 Model Number: 8881520673
• Device Catalogue Number: 8881520673
• Device Lot Number: 225558X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 04/20/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1