MAUDE Adverse Event Report: COVIDIEN 1ML TB SYR 25G X 5/8 DETACH RP; SYRINGE, PISTON

Model Number	8881501160
Medical Device Problem Code	Difficult to Advance (2920)
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
Customer reports: plungers are hard to pull and get stuck.
Additional Manufacturer Narrative
A device history record confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The manufacturing site received 100 packaged samples in a unit carto, unopened with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.No visual abnormalities were identified on the packaged syringe samples.A plunger activation force testing was conducted on a statistical sample size of 32 pieces.The result for the plunger movement force ranged from 0.22 ¿ 0.96 lbf.The results pass the specification of not more than 1.124 lbf average return force.All testing completed on the returned samples met specifications.Based on the test results on the return samples, as they samples did not demonstrate the reported condition, an exact root cause could not be determined.Probable root causes for the condition could be related to occlusion, insulin crystallization or uneven silicone within the syringe.All testing results were aligned with normal testing requirements and results.Process controls are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.In compliance with corporate and local procedures, safeguards are utilized to ensure all processes are controlled and cleaned regularly to minimize any process or product contamination.The control mechanisms are located at the plant and are confirmed on a regular basis to verify continuing efficacy.

• Brand Name: 1ML TB SYR 25G X 5/8 DETACH RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11693864
• Report Number: 1915484-2021-01233
• Device Sequence Number: 11739678
• 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: consumer,distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/14/2021

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: 8881501160
• Device Catalogue Number: 8881501160
• Device Lot Number: 034273X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 09/14/2021
• Patient Sequence Number: 1