MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 1ML TB SYR DTCH NDL 25X5/8; SYRINGE, PISTON

Model Number	8881501160
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that they have used several syringes but they are not allowing them to pull back on the syringe for blood collection.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
Based on a reassessment of additional event information received from the customer on (b)(6) 2023 and (b)(6) 2023 it has been determined that this event does not meet the criteria for medical device reporting therefore this report was filed in error.Please disregard the initial report and no additional follow up reports will be submitted.
Event or Problem Description
The customer reported that they have used several syringes but they are not allowing them to pull back on the syringe for blood collection.Additional information received from the customer on (b)(6) 2023 stated that when they were pulling blood, it did not have a negative pressure to it.On (b)(6) 2023 the customer clarified that the plunger was able to move but the rubber tip wasn¿t sealed to the barrel causing the no negative pressure.

• Brand Name: MONOJCT 1ML TB SYR DTCH NDL 25X5/8
• 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: 17995654
• Report Number: 1915484-2023-01328
• Device Sequence Number: 6123094
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2023

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 315673X
• 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: 10/05/2023
• Supplement Date Received by Manufacturer: 10/05/2023
• Initial Report FDA Received Date: 10/24/2023
• Supplement Report FDA Received Date: 10/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown