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

Model Number 8881501400

Device Problem Difficult to Advance (2920)

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

Event Date 08/22/2022

Event Type  malfunction  

Event Description

Customer reports: the syringe doesn't plunge, making it difficult to draw blood.

Manufacturer Narrative

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

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
• Type of Device: 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
• MDR Text Key: 305249697
• Report Number: 1915484-2022-01289
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Date Manufacturer Received: 08/22/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1