MAUDE Adverse Event Report: COVIDIEN 1/2CC E100 SAF 29X1/2; SYRINGE, PISTON

Model Number	8881511136
Medical Device Problem Code	Fail-Safe Problem (2936)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.
Event or Problem Description
Customer reports: the safety shield requires two hands and in doing so the nurses are getting close to being stuck because they are having to put a hand by the needle instead of a hinge needle that they were used to.Also the safety covering will slide over the needle prior to administration which requires someone to hold that down to be able to administer the medication.
Additional Manufacturer Narrative
The lot number was unknown per the customer report; without a known lot number, the device history record cannot be reviewed.The manufacturing site has not received any samples or photos for evaluation.Therefore, the reported issue could not be confirmed.Without additional information from the customer, a representative sample(s), or photograph(s) being provided, a more complete investigation cannot be performed to the full extent and the reported condition cannot be confirmed.In addition, without a sample or picture, a more definitive root cause cannot be determined at this time.Based on the description from the customer, it appears that they are describing the correct way to activate the safety shield.As per the instructions for use (ifu), fill syringe with medication while holding index finger against finger flange.Extend safety shield forward until you feel the positive stop and hear an audible snap.This will secure the safety shield for safe transportation to patient site.(note: picture shows that this activity requires the use of two hands).Do not twist safety shield or syringe.Once shield is locked by twisting, unit should be discarded.To give injection, retract safety shield until it snaps into its original position.To avoid unexpected extension of the safety shield, always keep one finger over the finger flange during use.Immediately following the injection, extend the shield forward fully until click is heard, then lock safety shield by twisting in either direction until you feel the positive stop and hear an audible snap.(note: picture shows this activity requires the use of two hands).Caution: when properly locked, safety shield should not retract.Keep fingers away from open end of the safety shield at all times.During the assembly of this product, inspectors routinely test samples for visual defects, shield retract force, shield extend force, shield-locking torque, shield/collar spin force, and detach force.The test results are reviewed for each shop order prior to release to verify that all testing during production was acceptable and within specification limits.The product cannot be accepted unless the acceptable quality level has been met.The plastic shield on the safety syringe is designed to slide forward to cover the needle to prevent needle sticks after use.The safety mechanisms will deactivate if you do not pull the shield all the way up and twist it.The instructions for use of the safety syringe are on the back of each unit box which state, ¿immediately following injection, extend shield forward fully until click is heard.Then lock safety shield by twisting in either direction until you feel the positive stop and hear the audible snap.Process controls are in place to prevent the occurrence and acceptance of the reported conditions during the molding, printing, assembly, and packaging processes, and to ensure components and finished product that meet all quality inspection standards during the syringe assembly processes.In compliance with corporate and local procedures, safeguards are utilized to ensure all processes are controlled and cleaned regularly to minimize any process or product contamination.The control mechanisms are located at the plant and are confirmed on a regular basis to verify continuing efficacy.

• Brand Name: 1/2CC E100 SAF 29X1/2
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 11755531
• Report Number: 1915484-2021-01244
• Device Sequence Number: 4229773
• Product Code: FMF
• UDI-Device Identifier: 20884521014944
• UDI-Public: 20884521014944
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/10/2021

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: 8881511136
• Device Catalogue Number: 8881511136
• Initial Date Received by Manufacturer: 04/05/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/30/2021
• Supplement Report FDA Received Date: 08/10/2021
• Patient Sequence Number: 1