MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 1ML TB SYR L-SLIP RP; SYRINGE, PISTON

Model Number	8881501400
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reports: the syringe doesn't plunge, making it difficult to draw blood.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The device history record (dhr) review showed syringes were visually inspected and physically tested with no issues recorded.The dhr indicates that product and specification requirements were met with no non-conforming product identified.No samples or photographs were received for evaluation.Without a sample, an investigation cannot be performed, and the reported issue cannot be confirmed.The root cause could not be determined.Complaint trends are evaluated during the monthly corrective and preventative action (capa) meetings to determine if a capa is warranted.At this time, a capa will not be initiated.The reported condition will be communicated to the appropriate quality and manufacturing personnel.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJCT 1ML TB SYR L-SLIP 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 ; 5086143640
• MDR Report Key: 15275919
• Report Number: 1915484-2022-01289
• Device Sequence Number: 6487062
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/04/2022

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: 8881501400
• Device Catalogue Number: 8881501400
• Device Lot Number: 215167X
• 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: 08/22/2022
• Supplement Date Received by Manufacturer: 08/22/2022
• Initial Report FDA Received Date: 08/23/2022
• Supplement Report FDA Received Date: 10/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown