MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 60ML SYR L-LOCK RP; SYRINGE, PISTON

Model Number	8881560125
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that a 60ml monoject syringe was used in a b braun pump for lipids and it failed to inject.They changed the pump and tubing, but the syringe still wouldn't inject properly.Per additional information received on september 8, 2022, the plunger was sticking.They had to get another set of lipids from the pharmacy to use in a different syringe.
Additional Manufacturer Narrative
The manufacturing site received one used sample with tubing that is not manufactured by cardinal health attached and a label from the end user attached to the side of the barrel for evaluation.A visual inspection to the quality inspection standard was conducted.Visual inspection of syringe observed zero defects such as evidence of an occlusion of the syringe tip, malformed rubber tip, etc.The plunger was exercised with the tubing attached and confirmed to be difficult to exercise the plunger.The tubing was removed, and the plunger was exercised without difficulty.Without a known lot number, the device history record (dhr) cannot be reviewed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.As a result of the current investigation, there were no manufacturing-related issues confirmed in relation to the syringe assembly.A potential cause may be in relation to other apparatus used in combination with the syringe assembly.A corrective action is not applicable at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 60ML SYR L-LOCK RP
• Common Device Name: SYRINGE, PISTON
• 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: 15473809
• Report Number: 1915484-2022-01292
• Device Sequence Number: 14161228
• Product Code: FMF
• UDI-Device Identifier: 20884521012230
• UDI-Public: 20884521012230
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 8881560125
• Device Catalogue Number: 8881560125
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2022
• Supplement Date Received by Manufacturer: 09/07/2022
• Initial Report FDA Received Date: 09/23/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown