MAUDE Adverse Event Report: COVIDIEN MONOJECT SAFETY NDL 25 X 1.5; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	1182515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/27/2019
Type of Reportable Event	Serious Injury
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 that the needle broke off in the patient's back while a trigger point injection was being done in ambulatory care.The patient was transferred to the emergency department.General surgery was attempted under fluoroscopy to try to remove the needle.The needle was not removed and the patient, with the needle still in his back, was sent home on pain medication.The surgeon and the anesthesiologist had decided to wait until the patient recovers from the exploring that they did to try to find the needle.
Additional Manufacturer Narrative
The device history record was reviewed and indicated that the product was released accomplishing all quality standards.A sample was returned for the evaluation.Upon sample analysis, the sample revealed a stretched cannula wall and cannula was missing since the needle broke off.During recreation test, it was found that the remnant section of the needle attached to the customer sample returned showed similar conditions when the cannula is bent beyond maximum specification angle.Per iso 9626:2016 the cannula breakage due to bending force should resist a maximum of 20 degrees bent.The supplier found no manufacturing issues on the product and confirmed that the product design remains being met.The needle breakage was likely due to the result of an excessive bending by the user during cannula insertion in patient.Functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for qa tracking and trending purposes.

• Brand Name: MONOJECT SAFETY NDL 25 X 1.5
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 9267323
• Report Number: 1282497-2019-08746
• Device Sequence Number: 2244296
• Product Code: FMI
• UDI-Device Identifier: 10884521544697
• UDI-Public: 10884521544697
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 01/17/2020

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: No Information
• Device Model Number: 1182515
• Device Catalogue Number: 1182515
• Device Lot Number: 18032709
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/28/2019
• Supplement Date Received by Manufacturer: 10/28/2019
• Initial Report FDA Received Date: 11/01/2019
• Supplement Report FDA Received Date: 01/17/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other