MAUDE Adverse Event Report: COVIDIEN 1ML TB SYRINGE 27G X 1/2; SYRINGE, PISTON

Model Number 1180127012

Device Problems Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)

Patient Problem Nausea (1970)

Event Date 01/18/2019

Event Type  malfunction  

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 Description

The customer reported that some of the needles come off the barrel when she tries to use them.The syringes that don¿t come apart have been filling in the yellow connector causing too much of the medication to be drawn and injected.Upon follow up with the patient on (b)(6) 2019, the patient stated that she is using a syringe/needle that comes attached but the needles and hubs detached from the syringe.She stated that the at the top of the needle there is a yellow piece that connects to the syringe and that is what is filling up with the chemo medication (methotrexate).She draws up the medication from a vial.The medication is not leaking out of the syringe or needle per se, but gathers inside the yellow connector area (what connects the needle to the syringe) rather than just in the barrel.She stated that she injects the medication once a week and has noticed the yellow part filled up twice and both of those weeks she felt sicker than usual (nausea) so she feels she gave herself too much medication.She did not see a doctor and there was no medication intervention.She has since switched to another product.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.819046x indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.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, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.The dhrs for shop orders of the syringe assemblies utilized in the production of this lot concluded visual and physical samples inspected identified no issues.There were no ncrs issued against the shop orders.A review of the entire dhr identified no manufacturing or inspection anomalies.A review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition for this product.Additionally, a review of the machine setup was conducted and revealed no issues.The investigation did not identify a systemic issue with the product or process.All hooded needle lots must pass incoming inspection before being accepted for release into production.The manufacture of the molded barrel is conducted within a validated process.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications.During the assembly of this product, inspectors routinely perform inspection for visual defects.Inspectors routinely perform inspection of physical functions, including leak testing and needle pull test.The leak test is conducted to verify the syringe draws, holds and expels fluid properly by inserting the syringe into a rubber block for resistance.The needle pull test measures the force required to detach the needle hub from the barrel luer.Inspections are reviewed for each shop order prior to release, in order to verify all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.Requests were made for sample return.However, no product/sample was provided for evaluation.No additional information, pictures or videos were received.Therefore, a comprehensive investigation was unable to be conducted.The reported customer complaint could not be confirmed.A root cause could not be determined.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML TB SYRINGE 27G X 1/2
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8337154
• MDR Text Key: 136144526
• Report Number: 1915484-2019-01017
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup
• Report Date: 03/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1180127012
• Device Catalogue Number: 1180127012
• Device Lot Number: 819046X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1