MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 25 X 5/8; SYRINGE, PISTON

Model Number	26549
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample has been requested but to date has not been received for evaluation.  if the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.  as part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that they have had to waste doses of vaccine this week due to the product leaking even though the staff was very diligent in tightening the needle to the syringe.There was no patient injury reported.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on june 02, 2020.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, samples are inspected for hub damage.The lot met the acceptance criteria and was released.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues found.All scheduled maintenance and calibration activities were completed.There were no related process or material changes related to the reported condition for this product.A review of the machine¿s setup was conducted and did not identify any issues.In addition, the equipment was reviewed for malfunctions or issues that could have contributed to the reported condition, but no such issues were observed during the review.Samples were not received for the investigation.One photo was provided; however, the photo only shows the product packaging, the reported issue could not be confirmed by viewing the photo.Because a sample was not returned, we were unable to perform a follow up investigation to include functional and visual evaluations to confirm the reported condition and determine the root cause.If samples are received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.A corrective action is not applicable at this time.There were no manufacturing related issues for this lot number and a specific root cause could not be determined based on all available information.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT 3ML COMBO 25 X 5/8
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11177364
• Report Number: 1017768-2021-00896
• Device Sequence Number: 19543274
• Product Code: FMF
• UDI-Device Identifier: 10612479201115
• UDI-Public: 10612479201115
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2021

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
• Operator of Device: No Information
• Device Model Number: 26549
• Device Catalogue Number: 26549
• Device Lot Number: 16076
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/14/2021
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 01/15/2021
• Supplement Report FDA Received Date: 03/03/2021
• Patient Sequence Number: 1