MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING

Model Number	1180327114E
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submit date: 5/7/2018.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states the monoject needle fractured from the base of the needle in a patients mouth.
Additional Manufacturer Narrative
Submission date: 08/17/2018.An investigation was performed for the reported customer complaint: ¿the customer states the monoject needle fractured from the base of the needle in a patients mouth.¿ a review of the device history record (dhr) for the reported lot number 704127 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.A review of changes to product, process, and packaging has been conducted identifying no affecting changes related to this reported event.Control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during the molding, printing, assembly and packaging processes.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, cannula pull force testing/assembly, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Device history records for all hypodermic needle product (item 4500133) that went into this lot were also reviewed.No deficiencies were noted.No product/samples were returned.There were no issues related to the reported condition found in a review of the dhrs, maintenance records, or process review.There is insufficient information available to determine a probable cause.The investigation did not identify a systemic issue with the product or process.The reported customer complaint is not confirmed.A root cause could not be determined.No corrective or preventive action is planned at this time.This complaint will be used for trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Common Device Name: SYRINGE, PERIODONTIC, ENDODONTIC, IRRIGATING
• Manufacturer (Section D): COVIDIEN; 2010 e international speedway; deland FL 32724 8707
• MDR Report Key: 7491440
• Report Number: 1017768-2018-00042
• Device Sequence Number: 196988
• Product Code: EIC
• UDI-Device Identifier: 30884521195541
• UDI-Public: 30884521195541
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Dentist
• Device Expiration Date: 01/31/2022
• Device Model Number: 1180327114E
• Device Catalogue Number: 1180327114E
• Device Lot Number: 704127
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/10/2018
• Supplement Date Received by Manufacturer: 04/10/2018
• Initial Report FDA Received Date: 05/07/2018
• Supplement Report FDA Received Date: 08/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other