MAUDE Adverse Event Report: COVIDIEN 12ML SYRINGE REGULAR NS; SYRINGE, PISTON

Model Number	8881112059
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2021
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 the syringe has ink on the inside near the bottom.At first it looked like the plunger but it is ink.
Additional Manufacturer Narrative
H3: evaluation summary: a device history record (dhr) review could not be performed because a lot number was not available; however, a lot will not be released without meeting all criteria.The sample was received at the manufacturing facility for evaluation.The sample analysis confirmed the syringe was missing 2 or more major graduation lines or 2 of 4 minor graduation lines.The ink is smeared from the 1ml mark down the proximal end of the syringe, causing the graduation lines between 0ml and 1ml to not be legible.The ink is adhered to the outside of the barrel.The lot number is not known precluding information about conditions at the time of manufacturing.The issue is consistent with issues caused by a worn doctor blade.If the lot was produced prior to 11/19/2020, then unclear procedures may have contributed to the occurrence.The standard operating procedure (sop) governing the printing process was updated on (b)(6) 2020 to define the product diverting process more clearly.No adverse trending signals were identified in production non-conformances or customer complaints per established trending thresholds.Based on the information available and the investigation findings, additional actions are deemed unnecessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.

• Brand Name: 12ML SYRINGE REGULAR NS
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 815 tek drive; crystal lake IL 60039 9002
• MDR Report Key: 11888664
• Report Number: 1424643-2021-00603
• Device Sequence Number: 14302737
• Product Code: FMF
• UDI-Device Identifier: 10884521010871
• UDI-Public: 10884521010871
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2021

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: 8881112059
• Device Catalogue Number: 8881112059
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 07/23/2021
• Patient Sequence Number: 1