MAUDE Adverse Event Report: COVIDIEN 35CC SYR CATH TIP; SYRINGE

Model Number 8881135316

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/07/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a syringe.The customer states the plunger tip is not properly affixed to the plunger rod.

Manufacturer Narrative

A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing quality requirements and released according to established procedures.The molded plunger inspection reports were reviewed with 0 defects recorded relating to this customer report.History record for the lot control indicates that product and specification requirements were met with no non-conforming product identified relating to this customer report.The actual sample(s) involved in the complaint event was received for evaluation.The manufacturing site received thirty-seven unpackaged syringe samples with this customer report.A complete investigation was performed.Visual inspection was conducted to the quality inspection standard.Improper assembly of the rubber tip onto the plunger rod was identified on each of the syringe samples.The support ring for the rubber tip on the plunger rod was partially inserted into the rubber tip i.D.The outside surface area of the plunger rod tip was damaged from the improper assembly of the rubber tip.The lab performed plunger activation and movement force testing on the thirty-seven syringe samples.Eleven of the syringe samples met the proposed force values documented in iso standards.The remaining twenty-six syringe samples exhibited force values up to 3.5x of the proposed force values documented in that iso.A pressurized leak test was performed at 45 psi on the thirty-seven syringe samples.Five of the syringe samples met the specification requirement of no leak past the second seal ring of the rubber tip at 100% of graduated volume.Thirty-two of the syringe assemblies did not meet the specification requirement of no leakage past the second seal ring of the rubber tip at 100% of graduated volume.A review of changes to product, process, and packaging has been conducted identifying no affecting changes in the previous 6 months.Potential contributing factors to incorrect assembly of the rubber tip onto the plunger rod include, but are not limited to: - mis-alignment of the rubber tip ¿plunger rod¿ printed barrel assembly station on the rotary assembly machine.- incorrect positioning of the rubber tip in the plunger assembly station.- incorrect timing of the plunger rod insertion into the rubber tip.- incorrect timing of the plunger assembly into the printed barrel.Timing of the assembly process is controlled by a mechanical cam.Detection sensors verify the presence of the rubber tip and plunger rod during the assembly process.Periodic verification of the detection sensors is conducted to ensure process capability is maintained.The following control mechanisms are in place to prevent the occurrence and acceptance of incorrect assembly during the molding, assembly and packaging processes: medtronic maintains material verification processes.The resin, colorant and rubber tips must pass various incoming inspection requirements prior to release to the floor for production.Procedures and work instructions exist for the proper handling and verification of components and the operation of the syringe assembly machine.Personnel are trained and certified in the operation of the molding, assembly and packaging equipment, product evaluation and documentation requirements.The manufacture of the molded plunger rod is conducted within a validated process.Critical process parameters are monitored and dimensions of the molded components are gauged to ensure molded components meet dimensional specifications.Visual and physical inspections are completed on a periodic basis.Molding tools are periodically maintained and inspected for wear or damage.Records of completed maintenance activities are maintained.The assembly of the syringe is conducted within a validated process.Detection sensors monitor assembly stations to verify the syringe components are correctly assembled.During production, the processing equipment is checked regularly to verify the detection systems are functioning properly.Daily cleaning and maintenance activities are implemented to ensure continuing process capability.After syringe assembly, the production associates conduct visual inspections and physical testing as required by the inspection procedure.A leak test is performed to ensure the syringe draws, holds and expels fluid properly.A lot cannot be released unless it passes visual and physical testing requirements.Based on the existing controls and the complaint history review, additional correction or containment activities are not warranted at this time.Based on the information available and the investigation findings, a corrective and preventative action (capa) is not deemed necessary at this time.

• Brand Name: 35CC SYR CATH TIP
• Type of Device: SYRINGE
• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd.; norfolk NE 68701
• Manufacturer Contact: thom mcnamara ; 15 hampshire st; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 5573986
• MDR Text Key: 43176802
• Report Number: 1915484-2016-00018
• Device Sequence Number: 1
• Product Code: PIF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881135316
• Device Catalogue Number: 8881135316
• Device Lot Number: 532035
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1