MAUDE Adverse Event Report: COVIDIEN 35ML SYRINGE LUER LOCK TIP RP; SYRINGE, PISTON

Model Number	8881535762
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2021
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 one of the syringes looked to be partially melted and the markings were off.Additional information received stated the markings were misprinted about 5 ml off from the zero.
Additional Manufacturer Narrative
The device history record for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The manufacturing site received one unsealed package containing a sample with this customer report.A complete investigation was performed.A visual inspection to the quality inspection standard was conducted.A low top line was identified on the syringe sample.There was also damage to the barrel thumb rest.The low top line can be confirmed on the syringe sample.The most probable root cause for the low top line barrel print is a result of damage to the base of the barrel.It is likely the barrel was not able to be fully seated properly on the pin at the barrel print station causing the print to be applied lower on the barrel.The most probable root cause for the damaged barrel is the part being caught during transfer within the aidilin during the assembly process.The following control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.

• Brand Name: 35ML SYRINGE LUER LOCK TIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 12233165
• Report Number: 1915484-2021-01263
• Device Sequence Number: 19873115
• Product Code: FMF
• UDI-Device Identifier: 20884521012193
• UDI-Public: 20884521012193
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2021

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: 8881535762
• Device Catalogue Number: 8881535762
• Device Lot Number: 109010X
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 07/19/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/13/2021
• Patient Sequence Number: 1