MAUDE Adverse Event Report: COVIDIEN MONOJECT SAFETY NDL 22 X 1.5; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182215
Medical Device Problem Codes	Material Puncture/Hole (1504); Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/08/2019
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.
Event or Problem Description
The customer reported that the needle punctured through the safety mechanism.
Additional Manufacturer Narrative
H 3: evaluation summary: the device history record (dhr) could not be reviewed because the lot number was unknown.One sample was received for evaluation.The sample confirmed the issue reported by the customer.The investigation team tried to reproduce the sample received from the customer.Simulation confirmed the bending of the needle at 50 degrees recreated the conditions present on the returned sample.The needle puncturing the safety mechanism is most likely caused by an excessive cannula bending.It was found that it was not possible that the needle cannula was bent prior to use by the customer because the needle cap cannot be assembled on the needle hub during the assembly phase of manufacturing if the needle is bent.The needle was most likely bent during or after the patient was injected.No corrective and preventative actions are deemed necessary at this time.The manufacturing site will continue monitoring the process for any adverse trends that require immediate attention.This complaint will be used for tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NDL 22 X 1.5
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire st; mansfield MA 02048
• MDR Report Key: 9316018
• Report Number: 1282497-2019-08768
• Device Sequence Number: 14080856
• Product Code: FMI
• UDI-Device Identifier: 10884521544659
• UDI-Public: 10884521544659
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 01/20/2020

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: 1182215
• Device Catalogue Number: 1182215
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/08/2019
• Supplement Date Received by Manufacturer: 11/08/2019
• Initial Report FDA Received Date: 11/13/2019
• Supplement Report FDA Received Date: 01/20/2020
• Patient Sequence Number: 1