MAUDE Adverse Event Report: COVIDIEN 35CC PLK BARL 535WOS TECH; SYRINGE, PISTON

Model Number 5551777518

Device Problem Material Fragmentation (1261)

Patient Problems Eye Injury (1845); Laceration(s) (1946)

Event Date 11/16/2018

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 reported that a syringe filled with potting material shattered onto an operator.She was cut on her chest, chin, and in one of her eyes under her safety glasses.Customer stated that the tube is extremely brittle and pieces crack easily.The customer mixes the potting material and fills the empty syringe, then attach the filled syringe to a time/pressure unit to dispense the material in a housing for potting.

Manufacturer Narrative

A review of the device history report (dhr) for lot no.819150x 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.Additionally, raw materials must pass an inspection and certification review before release to the floor for production.The manufacture of all molded, printed, assembled, and packaged product 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.Leak testing of the molded barrel is conducted to ensure no leakage through the barrel.A review of changes to product, process, and packaging has been conducted identifying no affecting changes related to the reported event.One (1) unpackaged sample was returned for evaluation.The sample was received in a shuttle with a yellow hooded needle assembly attached to the luer tip.The syringe barrel was cracked and broken, with approximately half of the barrel missing.There was a hardened brown-blackish colored substance inside the syringe barrel, which is likely the potting material the customer stated they were attempting to dispense from the syringe at the time of the incident.A piece of paper towel was stuck to the syringe barrel with the hardened potting material (brown-blackish substance).Broken pieces of the syringe barrel were included in the shuttle.The broken, incomplete and contaminated state of the sample was not conducive to a visual and physical inspection that meets the quality and inspection standard.During manufacturing, visual and physical inspection to the quality inspection standard was conducted.However, a thorough investigation was able to be performed.To further understand the reported event, additional research was conducted.The term ¿potting¿ was described within the complaint that an end-user mixes the potting material using a meter/mix piece of equipment and fills the empty syringe.Based on the information found during research activities, and based on the observation of the physical appearance of the shiny, hard, and dark ¿potting¿ on the sample received, it is possible that ¿potting¿ refers to some type of epoxy ¿potting¿ compound associated with some type of electronic assembly.A review of the iso standards was conducted, and in accordance with international standard iso7886-1:2017(e), for sterile hypodermic syringes for single use, annex d, under section d.2.3, the testing standards required for the industry to measure liquid leakage at the syringe plunger stopper under compression is for devices which generate pressures of 200 kpa ¿ which converts to 29.0075 psi, and 300 kpa- which converts to 43.5113 psi.The design verification activities for the syringe would have been verified in compliance with the international standard iso7886-1:2017(e), for sterile hypodermic syringes for single use.The potential maximum pressure of ¿up to 100 psi¿, that the customer reported, ¿to dispense the material in the housing for potting when they attach the filled syringe to a time/pressure unit¿, would not have been evaluated as part of the design verification activities for the syringe.The investigation was unable to evaluate how the storage/handling of the medical device during preparation and use may have affected the syringe.Since the syringes were reported to have broken during use, full assessment of all contributing factors could not be performed.A definitive root cause could not be determined.Identification of potential contributing factors (potential causes) of the reported condition include, but are not limited to: 1) off label use, in which the potential maximum dispensing pressure of ¿up to 100 psi¿ exceeds the design verification activities for the syringe that would have been verified in compliance with the international standard iso7886-1:2017(e), for sterile hypodermic syringes for single use; 2) potentially there may have been some type of damage on the syringe that was not visually obvious prior to customer preparation; or, 3) misalignment of the syringe into the pressure unit during preparation and use.The reported customer complaint is confirmed.A root cause could not be determined.A most likely root cause was determined to be user misuse.This complaint will be used for tracking and trending purposes.

• Brand Name: 35CC PLK BARL 535WOS TECH
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701
• MDR Report Key: 8271771
• MDR Text Key: 133893483
• Report Number: 1915484-2019-01013
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 5551777518
• Device Catalogue Number: 5551777518
• Device Lot Number: 819150X
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/16/2019
• Patient Sequence Number: 1
• Patient Outcome(s): Other