MAUDE Adverse Event Report: CARDINAL HEALTH PREVENT 3ML COMBO 23 X 1; SYRINGE, PISTON

Model Number	26547
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 the thread on the syringe does not appear deep enough to hold the needle in place.The syringe has come off 3 times while administering thicker injections, causing needle to remain in patient's leg.Per additional information received, the needle was immediately removed without any further interventions needed.The needle and hub remained intact, together, they detached from the luer of the syringe.
Additional Manufacturer Narrative
The device history record (dhr) was reviewed and indicated that the product was released accomplishing all quality standards.The device was produced between 01/12/2019 and 01/14/2019.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.The lot met all defined acceptance requirements and was released.Seventy-three unused physical samples were received for the investigation.Visual inspection, luer taper test, and water test were performed.The reported condition could not be confirmed.The true root cause of the reported failure could not be determined based on available information.There were no anomalies found during a review of the dhr¿s, maintenance records, or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a new corrective and preventative action is not required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT 3ML COMBO 23 X 1
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 13693328
• Report Number: 1017768-2022-01000
• Device Sequence Number: 5295354
• Product Code: FMF
• UDI-Device Identifier: 10612479201054
• UDI-Public: 10612479201054
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2022

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: 26547
• Device Catalogue Number: 26547
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/15/2022
• Supplement Date Received by Manufacturer: 02/15/2022
• Initial Report FDA Received Date: 03/08/2022
• Supplement Report FDA Received Date: 07/29/2022
• 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