MAUDE Adverse Event Report: SOL-MILLENNIUM MEDICAL COVIDIEN MONOJECT HYPODERMIC SAFETY NEEDLE

Model Number	1182515
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/27/2019
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the safety needle broke off in a patient's back while receiving a trigger point injection on (b)(6) 2019 in ambulatory care.The patient was transferred to the emergency department.General surgery [health professional] then attempted under fluoroscopy to perform an i&d to try to remove the needle.At the time of the report, the patient was waiting in the operating room, as c-case emergency surgery to remove this foreign body.
Additional Manufacturer Narrative
Patient follow-up information: the end user said that the patient still had the needle lodged in his back as of (b)(6) 2019 and he was pain free.Per the end user, there was most likely no plan to attempt to remove the needle at this time.The complaint information, manufacturing process information was reviewed by the r&d quality engineer.The customer unit was received and evaluated by the r&d quality engineer.The manufacturing process information was reviewed.The production site checked the batch records of impacted safety needle lot#18032709.The batch was produced on (b)(6) 2018 using the standard process with no variances found on batch documentation.Sol-millennium released this lot on 08/1/2018.A total of 20 archived samples of affected lot# were checked via naked eye per inspection standard rm20013898.No cosmetic defects were found on the needle.The production site randomly selected 5 archived samples of affected lot# to test the bond force between cannula and needle hub with 22n weight according to iso 7864:2016.All of the samples passed testing.The production site then tested 5 archived samples of affected lot# to do cannula stiffness test according to the method defined in iso 9626:2016 annex b.All of the samples passed cannula stiffness testing.Lastly, production site tested 5 archived samples of affected lot# to do cannula resistance to breakage test according to the method defined in iso 9626:2016 annex c.All of these samples also passed testing.There was no evidence that any needle defect happened during manufacturing phase.A review of complaints of the last two years reveals that only one complaint for safety needle 27gx1/2'' that was received in 2018 for broken cannula of safety needle.No trend was identified for needle breakage while in patient.Sol-millennium will continue to monitor this type of issue.R&d office based in switzerland received the customer unit on 17th december 2019.The needle cannula was broken and missing on the returned unit.The breaking point was immediately at the end of glue used to fix the cannula to the needle hub, with a remnant of the cannula remaining in the hub.The needle breaking point was checked using visual microscope with magnification 40x, there were traces of medication and probably blood at the breakage point.The cannula wall in the cannula remnant was stretched out and ovalized.After checking laterally using magnification 20x, it was clear that needle cannula was bent during breakage.It is not possible that 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.The needle cannula was most likely bent during patient injection.To confirm this hypothesis, the r&d engineer performed a simulation test by bending the cannula over the limit.The breaking point was seen immediately at the end of glue in the simulated test sample and is at the same position as the received customer unit.The simulated sample was also checked using a visual microscope with magnification 40x and cannula wall in the final part of breaking point was stretched out and ovalized, very similar to received customer unit.According to iso 9626:2016 (test method for resistance of tubing to breakage), it is required that the cannula does not break after bending in one plane through an angle of 20° for thin wall cannula, such as a sol-m needle cannula, and in the reverse direction for a total of 20 cycles.An angle of 20° is a worst-case high angle, because normally this angle is not reached while cannula pierces the skin during an injection.However, if the end user during insertion, bends the needle accidentally more than an angle of 20°, it is possible that the cannula breakage will occur due to a use beyond its specifications.No manufacturing defect was found.The design continues to meet design requirements.The needle breakage is most likely caused by an excessive bending by the user during cannula insertion in patient.There is no evidence of a trend.No immediate corrective action is required.No corrective actions are planned.We will continue to monitor the product for reoccurrence.

• Brand Name: COVIDIEN MONOJECT HYPODERMIC SAFETY NEEDLE
• Common Device Name: SAFETY NEEDLE
• Manufacturer (Section D): SOL-MILLENNIUM MEDICAL; 315 shawnee north dr.; suite 100; suwanee 30024
• MDR Report Key: 9390397
• Report Number: 3014312726-2019-00002
• Device Sequence Number: 2100715
• Product Code: FMI
• UDI-Device Identifier: 10884521544697
• UDI-Public: 10884521544697
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K123684
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/28/2019

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 Expiration Date: 03/27/2023
• Device Model Number: 1182515
• Device Catalogue Number: 1182515
• Device Lot Number: 18032709
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 10/31/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 11/28/2019
• Supplement Report FDA Received Date: 01/11/2020
• 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: Required Intervention