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

Model Number	8881501160
Medical Device Problem Code	Air/Gas in Device (4062)
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
The customer reported when the technicians are drawing the blood up, the syringes tend to get air and the plunger is extremely flimsy and bends when pulling it back.The seal seems to be fine with them.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed showing syringes were visually inspected and physically tested with no issues recorded relating to this customer report.Samples were received for evaluation.A visual inspection was conducted showing a missing rubber tip in one of the syringe samples received.No other issues were observed.Restriction testing and leak testing was performed on a statistical sample size of the returned product.The restriction testing and leak testing showed all syringes passed testing.The reported condition could not be confirmed.The root cause could not be determined from the returned samples.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.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.However, the reported condition will be communicated to the appropriate quality and manufacturing personnel.This complaint will be used for tracking and trending purposes.
Additional Manufacturer Narrative
Additional information: d4 lot number was added.

• 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: 15074372
• Report Number: 1915484-2022-01283
• Device Sequence Number: 5527187
• Product Code: FMF
• UDI-Device Identifier: 20884521013954
• UDI-Public: 20884521013954
• 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: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/26/2022

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 203815X
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/14/2022
• Supplement Date Received by Manufacturer: 07/14/2022; 07/14/2022
• Initial Report FDA Received Date: 07/21/2022
• Supplement Report FDA Received Date: 08/03/2022; 08/26/2022
• 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