MAUDE Adverse Event Report: COVIDIEN PREVENT 3ML COMBO 25 X 1; SYRINGE, PISTON

Model Number	26548
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was discarded however the initial reporter stated a representative is available 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 the plunger felt sticky and that the nurse couldn't push medication (b12) into the patient's arm.
Additional Manufacturer Narrative
The device history record (dhr) for the lot shows no issues found in visual and physical samples inspected.The review did not identify additional manufacturing or inspection anomalies.There was one (unused, unopened) sample returned with this complaint.A physical leakage test for the syringes was performed.The sample passed the test and no signs of difficulty moving the plunger were found.The reported condition is not confirmed.The exact root cause could not be determined based on the available information.The investigation analysis did not identify any issues with the manufacturing process that would have caused this issue.This product is distributed sterile in a needle syringe combo configuration.The needle with syringe is ready for use (needle attached to luer lock syringe).There were no indications of any issues through the manufacturing process that can point to insufficient lubricant sprayed into the syringe.Additionally, the application of the device could not be verified from the information present in the complaint.Based on this analysis, this root cause cannot be confirmed or discarded from consideration, so it remains as a potential cause.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 plunger actuation.The lot met the acceptance criteria and was released.There were no manufacturing issues related to the complaint issued for this lot and a specific root cause could not be determined based on available information.There¿s no indication of a systemic issue with the product or process, so a corrective and preventative action (capa) will not be issued at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: PREVENT 3ML COMBO 25 X 1
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 8911278
• Report Number: 1017768-2019-00670
• Device Sequence Number: 10891114
• Product Code: FMF
• UDI-Device Identifier: 10612479201085
• UDI-Public: 10612479201085
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 11/22/2019

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: 26548
• Device Catalogue Number: 26548
• Device Lot Number: 824110
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/12/2019
• Supplement Date Received by Manufacturer: 08/12/2019
• Initial Report FDA Received Date: 08/20/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1