MAUDE Adverse Event Report: COVIDIEN 10 CC SALINE 12 ML SYRINGE SFF; SALINE, VASCULAR ACCESS FLUSH

Model Number	8881570121D
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/23/2020
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 the saline solution inside of the syringes was cloudy.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.Review of the incoming inspection reports for the syringes used in this batch showed that they were in-conformance and were released accordingly.The equipment used was in proper functioning condition during the manufacturing, filling and packaging of this lot.Review of the manufacturing records for this lot confirmed that all test results, including chemical and microbiological testing, met acceptance criteria at release.In addition, each lot is released based on an aql sampling which includes the verification for a solution not clear or not colorless.As per the final quality inspection report of this lot, all criteria were conforming.The product was in conformance to our specifications and was released for distribution meeting all established quality assurance acceptance levels.One photograph was provided for the investigation.A visual evaluation was completed, and the reported issue could not be confirmed.The photo shows a syringe barrel with the label.The syringe appearance is cloudy however the haziness of the syringe barrel is normal, this is not a fault as the syringes are not made of a clear plastic.It is to be noted that the plastic of the syringe has a little haze that could be mistaken for the solution being cloudy.Physical samples were not received for the investigation.Because a physical sample was not returned, we were unable to perform a follow up investigation to include functional evaluations.If a physical sample is 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 is no impact on the lot as the product was in conformance to our specifications and was released for distribution meeting all established quality assurance acceptance levels.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: 10 CC SALINE 12 ML SYRINGE SFF
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA
• MDR Report Key: 10018988
• Report Number: 1282497-2020-09048
• Device Sequence Number: 2968140
• Product Code: NGT
• UDI-Device Identifier: 10884521750173
• UDI-Public: 10884521750173
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/20/2020

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: 8881570121D
• Device Catalogue Number: 8881570121D
• Device Lot Number: 18H1524
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/23/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 05/01/2020
• Supplement Report FDA Received Date: 08/20/2020
• Patient Sequence Number: 1