MAUDE Adverse Event Report: COVIDIEN MONOJECT; SYRINGE, PISTON

Model Number 8881535762

Device Problem Contamination (1120)

Patient Problem No Patient Involvement (2645)

Event Date 10/09/2018

Event Type  malfunction  

Manufacturer Narrative

Submit date: 10/25/2018.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.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports: the bung has black bits caught down the side.Looks like rubber is splitting away and the other issue was the plunger is noticeably damaged and bent inside the barrel.

Manufacturer Narrative

Submission date 01/11/2019.An investigation was performed for the reported customer complaint: ¿the customer reports: the bung has black bits caught down the side.Looks like rubber is splitting away and the other issue was the plunger is noticeably damaged and bent inside the barrel.¿ a review of the device history record (dhr) for lot no.733826x 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, procedures and standard work instructions exist for the setup, operation, and maintenance of the molding/forming machines, printers, fillers, and assembly machines.Cleaning and maintenance requirements are defined and implemented to ensure continuing process capability.During the manufacturing of this lot, syringes were visually inspected and physically tested with no issues recorded relating to this customer report.Potential issues that are inspected for include, but are not limited to, damaged product or components and improper assembly of the product and components.The molded plunger inspection reports were also reviewed with no issues recorded.The relevant shop orders indicated that all product and specification requirements were met with no non-conforming product identified relating to this customer report.It is also important to note, all raw materials purchased and used in the manufacture of products are from approved suppliers only.This syringe is intended to be a single use syringe and not qualified as a prefill syringe.Eight (8) unpackaged samples were received for evaluation.Visual inspection was conducted.Damaged/warped plunger rod was identified on six (6) of the syringe samples.The warpage caused the rubber tip to not seat properly on the plunger tip.Skived rubber tip was identified on two (2) of the syringe samples.The skived material was still attached to the side of the rubber tip on one (1) of the syringe samples.The material was unattached from the rubber tip on the second syringe sample and was attached to the underside of the plunger tip.No particulate or extraneous matter was identified to be within the fluid pathway.Leak testing was performed.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.All eight (8) of the sy ringe samples passed the leak testing.As a result of a thorough investigation and product analysis, the following has been determined: two (2) of the samples provided are confirmed to contain the issue of damaged/torn rubber tip rendering device non-functional.Six (6) of the samples provided are confirmed to contain the issue of damaged plunger.Throughout the manufacture of this product, the following process controls are in place: during the molding process of the plunger rod: a sampling is collected at startup and visually inspected and physically tested to verify components are within specification.Throughout the length of production, one complete shot of parts are collected at least every 1-4 hours depending on sampling plan and visually inspected for issues including but not limited to ¿malformations, flash, short shots, or damage that would impair function¿, ¿holes or splits that may allow loss of sterility or permit leakage¿, and warpage.Throughout the length of production, one complete shot of parts are collected at least once every 4 hours of production to perform physical testing.This includes leak testing and measurement of critical dimensions.During the plunger/rubber tip syringe assembly: a sampling is collected at startup and visually inspected and physically tested to verify components are within specification.Throughout the length of production, a sampling is collected and visually inspected at least once every 2 hours to inspect for visual irregularities including but not limited to ¿damaged product or components¿, flash, and incomplete or incorrect assembly of product.Throughout the length of production, depending upon the issue being inspected for, a sampling is collected at least every 2 hours to perform physical testing.Samples are collected at prescribed intervals and provided to the laboratory to be tested for volumetric testing to verify syringes are within specification.The most probable root cause for the damaged plunger rod has been determined to be due to a slight machine misalignment during the a ssembly of the plunger rod and syringe barrel.The plunger rods are molded on a separate machine and then transferred directly over to the assembly process by air glides to the drop-down stations.This is then where the plunger rod is assembled with the syringe barrel.The plunger rod is then mechanically pushed over to align it with the plunger tip which is previously inserted in to the syringe barrel.The plunger is then inserted in to the barrel, which also simultaneously applies the rubber tip to the plunger rod.It is likely the solenoid that pushed the plunger rod in to align with the rubber tip and syringe barrel was slightly out of alignment.This can potentially cause damage to the plunger rod and/or damage to the rubber tip during insertion.The reported customer complaint was confirmed for two (2) of the samples for the issue of damaged/torn rubber tip.The reported customer complaint was confirmed for six (6) of the samples for the issue of damaged plunger.The most probable root cause for the damaged plunger rod has been determined to be due to a slight machine misalignment during the assembly of the plunger rod and syringe barrel.This issue will be communicated to the appropriate manufacturing and quality assurance personnel to heighten awareness of the reported condition.No further corrective actions are planned at this time.This complaint will be utilized for tracking and trending purposes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: MONOJECT
• Type of Device: SYRINGE, PISTON
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• MDR Report Key: 8006433
• MDR Text Key: 125122510
• Report Number: 1915484-2018-00047
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10884521012196
• UDI-Public: 10884521012196
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2023
• Device Model Number: 8881535762
• Device Catalogue Number: 8881535762
• Device Lot Number: 733826X
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/08/2019
• Patient Sequence Number: 1