MAUDE Adverse Event Report: COVIDIEN 1ML SAF SYR ETB 25X 5/8; SYRINGE, PISTON

Model Number 8881511235

Device Problem Nonstandard Device (1420)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

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 stated there were two needles inside the safety device, one was pointed in the opposite direction and was not seen until the safety shield was engaged.When the safety shield was engaged after use, one of the needles stuck the health care provider.

Manufacturer Narrative

A device history record review could not be performed because a lot number was not received with the complaint.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to the release of product.

Manufacturer Narrative

A physical sample was not received for the investigation, but one photo was provided.A visual evaluation was completed, and the reported issue was confirmed.The picture shows a safety syringe without the product id or lot number visible.The syringe does appear to have two cannulas present.One of the cannulas appears to be correctly set in the tip of the syringe while the other appears bent and poking out past the safety shield.It cannot be determined from the picture if the bent cannula is attached to the tip of the syringe or if it is a lone cannula not attached to the syringe.Without a representative sample being provided, a more complete investigation cannot be performed to the full extent.Based on the picture provided it is speculated that the bent cannula under the safety shield is a result of two cannulas being inserted into the tip of the syringe.One of those cannulas was likely bent or off center so much that the cannula detect sensor did not recognize the second cannula to remove the syringe from the production line.The following control mechanisms are in place to prevent the occurrence and acceptance of the reported condition during molding, printing, assembly, and packaging processes, and to ensure components and finished product meet all quality inspection standards during the syringe assembly processes.The manufacturing site maintains material verification processes.The raw materials must pass an inspection and certification review before release to the floor for production.The manufacture of all molded components is conducted within a validated process inside a controlled manufacturing area.The critical dimensions of the molded components are gauged to ensure molded components meet dimensional specifications and are visually and physically tested for adherence to the quality inspection standard.If problems were detected during processing, non-conforming product would be identified and segregated.Molding, printing, assembly, and packaging machine maintenance requirements are documented.Records of maintenance activities are maintained.Personnel are trained and certified in the operation of the molding, printing, assembly, and packaging equipment.Personnel are trained and certified in the process of product evaluation and documentation requirements.During manufacturing, process inspectors inspect product at periodic intervals to ensure it meets acceptable quality limits.Process inspectors are required to conduct visual and physical evaluations at prescribed intervals and cannot release product unless the required aql has been met per the specification.Procedures and standard work instructions exist for the set-up, operation, and maintenance of the molding machines and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.All lots and shop orders are visually and physically inspected to the quality inspection standard and the statistical sampling must meet the acceptable quality limit requirements during the molding and assembly process.A lot cannot be released unless it passes specification requirements.A corrective action is not applicable at this time.No trend has been identified and functional testing and visual inspections are being performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.

• Brand Name: 1ML SAF SYR ETB 25X 5/8
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 10227499
• MDR Text Key: 197406024
• Report Number: 1915484-2020-01174
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 20884521014975
• UDI-Public: 20884521014975
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 8881511235
• Device Catalogue Number: 8881511235
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other