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)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
Customer reported that the plunger detaches from the stopper when you pull back and when you try to inject it is extremely hard to push it.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the condition described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The manufacturing site received ninety-three packaged syringes in a unit carton with this customer complaint.A complete investigation was performed.Ninety-one of the syringes were identified as 1ml tuberculin syringes lot 310753x.Two of the syringe samples received were not manufactured at the norfolk site.A visual inspection was conducted on the ninety-one of the syringes and there were no issues identified.A restriction test was performed on 91 samples by restricting the luer tip of the syringe and extending the plunger rod to syringe capacity to verify no plunger rod and rubber tip separation.All ninety-one of the syringe samples passed the restriction testing therefor the reported condition of the plunger rod and rubber tip separation cannot be confirmed.A leak testing was performed on thirty-two of the syringe samples received.The leak test is conducted to verify the syringe draws, holds and expels fluid properly by inserting the syringe into a rubber block for resistance.All thirty-two of the syringe samples passed the leak testing.No visual inspection or physical testing was completed on the two syringes that were not manufactured at the cardinal health site.All lots and shop orders are visually and physically inspected to the quality inspection standard and the statistical sampling must meet the acceptable quality limit requirements during the molding and assembly process.A lot cannot be released unless it passes specification requirements.The investigation did not identify a systemic issue with the product or process, no trend exists for the failure mode, therefore a specific root cause could not be identified based and a corrective and preventive action (capa) is not necessary at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MONOJCT 1ML TB SYR L-SLIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street, mansfield, ma; 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: 17213733
• Report Number: 1915484-2023-01318
• Device Sequence Number: 3010867
• Product Code: FMF
• UDI-Device Identifier: 10884521014053
• UDI-Public: 10884521014053
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 08/23/2023

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: 8881501400
• Device Catalogue Number: 8881501400
• Device Lot Number: 310753X
• 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: 06/26/2023
• Supplement Date Received by Manufacturer: 06/26/2023
• Initial Report FDA Received Date: 06/27/2023
• Supplement Report FDA Received Date: 08/23/2023
• 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