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
Evaluation summary: the device history record (dhr) for the lot shows no issues found in visual and physical samples inspected.The review of the dhr did not identify additional manufacturing or inspection anomalies.There were 2 (unused, unopened) samples returned with this complaint.A physical leakage test for the syringes was performed.Both samples returned from the customer passed physical testing for plunger actuation.The reported condition is not confirmed.The exact root cause could not be determined based on the available information.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 is 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: 8911272
• Report Number: 1017768-2019-00669
• Device Sequence Number: 16255827
• 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): 11/15/2019

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: 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1