MAUDE Adverse Event Report: CARDINAL HEALTH 3ML SYRINGE 22G X 1 RP; SYRINGE, PISTON

Model Number	8881513231
Medical Device Problem Code	Fluid/Blood Leak (1250)
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 that about 1/3 of the box is leaking through the plunger.The product was used in a veterinary setting.Additional information provided stated that the syringe doesn't appear to have any problems.The plunger is seated correctly.
Event or Problem Description
The customer reported that about 1/3 of the box is leaking through the plunger.The product was used in a veterinary setting.Additional information stated that the syringe doesn't appear to have any problems.The plunger is seated correctly.The customer also stated there is not an expiration date on the carton.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, the samples will be inspected for leaks and verify the lot number/print on the boxes, if required.The lot met all defined acceptance requirements and was released.Photos of the carton and one unused, opened device was returned for evaluation.A functional test was performed on the syringe; the reported condition was not confirmed.The root cause of the failure could not be determined based on available information.There were no anomalies found during a review of the dhr, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Also, there was no trend observed.The photos of the carton were also reviewed for the reported issue of missing expiration date.However, the reported product does not have an expiration date, hence is not printed.Based on the investigation and root cause analysis, the initiation of a corrective and prevention action is not required at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: 3ML SYRINGE 22G X 1 RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west st; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west st; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 16000232
• Report Number: 1017768-2022-01039
• Device Sequence Number: 5793713
• Product Code: FMF
• UDI-Device Identifier: 10884521012714
• UDI-Public: 20884521012711
• 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: Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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: 8881513231
• Device Catalogue Number: 8881513231
• Device Lot Number: 22K375
• 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: 12/14/2022
• Supplement Date Received by Manufacturer: 12/14/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown