MAUDE Adverse Event Report: COVIDIEN 135 S-PLK X SP NO LOGO; SYRINGE, PISTON

Model Number	8881135019
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2021
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 they detected during incoming inspection, syringes with damage to the tip.
Additional Manufacturer Narrative
Additional information: the device history record (dhr) for the reported lot was reviewed.During the manufacturing of the syringe assemblies, syringes were visually and physically tested with no issues recorded relating to this customer report.During the barrel printing process, printed barrels were visually inspected with no issues recorded relating to this customer report.The lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.Photos were provided for evaluation.In the first photograph, five unpackaged 35 ml syringes can be observed.The barrel printing is not shown in the first syringe, however, a portion of the base of the plunger rod is broken and missing.In the remaining four syringes, the barrel print is shown.The first and third syringes are missing a small portion of the ¿5¿ in the ¿35¿ ml graduation numeral.The print is still legible and cannot be construed as any other number.The second syringe does not appear to have any print or barrel defects present.The fourth syringe appears to have a portion of the ¿0¿ in the ¿10¿ ml graduation numeral missing and potentially illegible.The lighting in the photograph provided slightly interferes with certainly being able to verify the fourth syringe barrel print condition.In the second photograph provided, one syringe tip with a split and broken luer is present.The manufacturing site did not receive any samples with this customer report.Without a sample, a more complete investigation cannot be performed, and the reported conditions cannot be confirmed to be manufacturing-related.The exact root cause could not be determined without a physical sample to evaluate.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 (qis) during the syringe assembly processes.The manufacturing site maintains a material verification processes.The raw materials must pass an inspection and certification review before release to the floor for production.The manufacture of all molded components is conducted within a validated process inside a controlled manufacturing area.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications and are visually and physically tested for adherence to the qis.If problems were detected during processing, non-conforming product would be identified and segregated.Molding, printing, assembly, and packaging machine maintenance requirements are documented.Records of maintenance activities are maintained.Personnel are trained and certified in the operation of the molding, printing, assembly, and packaging equipment.Personnel are trained and certified in the process of product evaluation and documentation requirements.During manufacturing, process inspectors inspect product at periodic intervals to ensure it meets acceptable quality limits (aql).Process inspectors are required to conduct visual and physical evaluations at prescribed intervals and cannot release product unless the required aql has been met per the specification.Procedures and standard work instructions exist for the set-up, operation, and maintenance of the molding machines and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.Various validated detection units such as a rubber tip detection unit, plunger detection unit, barrel blow-out probe, and print tape break detectors are in place and verified at prescribed intervals to verify functionality.Air pressure for blow-over tubes is monitored and adjusted when necessary.A lot cannot be released unless it passes specification requirements.Per procedure, complaint trends are evaluated during the monthly corrective and preventative action (capa) meeting to determine if a capa is warranted.At this time, a capa will not be initiated.However, these conditions will be communicated to the appropriate manufacturing and quality assurance personnel to heighten awareness of the reported condition.This complaint will be used for tracking and trending purposes.

• Brand Name: 135 S-PLK X SP NO LOGO
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11999242
• Report Number: 1915484-2021-01257
• Device Sequence Number: 11838723
• Product Code: FMF
• UDI-Device Identifier: 10884521010819
• UDI-Public: 10884521010819
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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): 08/02/2021

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: 8881135019
• Device Catalogue Number: 8881135019
• Device Lot Number: 002088
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/25/2021
• Supplement Date Received by Manufacturer: 05/25/2021
• Initial Report FDA Received Date: 06/15/2021
• Supplement Report FDA Received Date: 08/02/2021
• Patient Sequence Number: 1