MAUDE Adverse Event Report: COVIDIEN 60ML SYRINGE LUER LOCK (NS); SYRINGE, PISTON

Model Number	8881160629
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2019
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 reports issues with nicks/damage and bubbles near the luer tip.
Additional Manufacturer Narrative
The lot number provided, lot no.63889, is not a valid cardinal health lot number.Without a valid lot number, the device history record cannot be reviewed.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.The manufacturing site received six unpackaged samples with this customer report.A complete investigation was performed.Slightly damaged luer tip was identified on four of the syringe samples.Leak testing was conducted on all six of the syringe samples.The leak test is conducted to verify the syringe draws, holds and expels fluid properly by inserting the syringe into a rubber block for resistance.All the syringes passed the leak testing therefore the reported issues would not affect the function of the barrel.Examination of the four samples with the damage to the luer tip was not able to find an exact root cause but did identify a potential root cause which could be the result of the tip rubbing against another syringe.Based on the information available and the investigation findings, a corrective action is not applicable at this time.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: 60ML SYRINGE LUER LOCK (NS)
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8790534
• Report Number: 1915484-2019-01061
• Device Sequence Number: 16804024
• Product Code: FMF
• UDI-Device Identifier: 10884521010963
• UDI-Public: 10884521010963
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/24/2019

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: 8881160629
• Device Catalogue Number: 8881160629
• Device Lot Number: 63889
• Initial Date Received by Manufacturer: 07/09/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 10/24/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1