MAUDE Adverse Event Report: COVIDIEN MONOJECT; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182705
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Submit date: 3/14/2017.An investigation is currently under way; upon completion the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states the needle is dull, it is hard to put the needle no the syringe and the needles falls off during injection.
Additional Manufacturer Narrative
He returned samples were sent to the supplier however the supplier confirmed that the samples had been lost before the evaluation therefore the supplier was able to provide the following investigation: the device history record (dhr) was reviewed for lot 16051902, and no abnormal process conditions were present during the manufacturing of the product that could have led to the defect described by the customer.The dhr review showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.The supplier chose 20 reserve samples of lot 16051902 to do the needle penetration force test and all penetration forces met product specification and iso standard.Also, the conical fitting of the archived samples were tested and all meet product specification and iso standard.Using a standard luer gauge (type 6:100) to measure the needle hub of a safety needle (the needle size is 23g but it is with same needle hub size as the one for lot 16051902).The tested sample is within the specification.Since the syringe type or sample was lost; the testing for tight fit of the connection between the safety needle and the syringe could not be taken.Based on above investigations, and a review of complaint history for dull issue involving product, the root causes could not be determined therefore this complaint will be closed and used for trending purpose at this ti me.If additional information is obtained, this file may be re-opened for further investigation and the supplier will take the corrective action asap.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire st.; mansfield MA 02048
• MDR Report Key: 6403707
• Report Number: 3011410703-2017-00049
• Device Sequence Number: 34712
• Product Code: FMI
• UDI-Device Identifier: 30884521544769
• UDI-Public: 30884521544769
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2017

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: Health Professional
• Device Expiration Date: 04/19/2021
• Device Model Number: 1182705
• Device Catalogue Number: 1182705
• Device Lot Number: 16051902
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/14/2017
• Supplement Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/14/2017
• Supplement Report FDA Received Date: 11/22/2017
• 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