MAUDE Adverse Event Report: COVIDIEN

Model Number 8881160225

Device Problem Contamination of Device Ingredient or Reagent (2901)

Patient Problem No Patient Involvement (2645)

Event Date 05/03/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 06/01/2017.An investigation is currently underway.Upon completion, the results will be forwarded.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports plastic debris was found in the fluid path.

Manufacturer Narrative

A device history record review of the reported lot number(s) confirmed that the product was produced accomplishing all quality requirements and released according to established procedures.During the manufacturing of the syringe assemblies, 2,048 syringes were visually inspected and 1 ,029 syringes were physically tested with zero issues recorded relating to this customer report.The molded syringe barrel inspection reports were reviewed with zero issues recorded relating to this customer report.No non-conforming product identified relating to this customer report.The molding maintenance work orders and mold repair cavitation were reviewed.There were no unusual repairs identified.And the records demonstrated regular product maintenance (pm).The molding machine daily cleaning and maintenance checklist records were reviewed.There were no issues identified.A complete investigation of the syringe sample returned for evaluation was performed to the quality inspection standards (qis).Particulate matter was identified on the inside diameter of the syringe barrel, on the face and side of the rubber tip.Damage to the stop ring feature of the syringe barrel was identified.The reported condition of particulate in the fluid pathway is confirmed in the one syringe sample.In accordance with quality information system (qis) ¿major a, aql=.065, particulates and extraneous matter in fluid pathway.¿ per aql inspector slide rule, ansi/asq z1.4-2008, one defect at an aql of.065 is within the acceptable quality limits for a lot size of 100,125 pieces.Sample size of 800 with acc.1/ 2 rej.A definitive root cause was not determined, but the potential root cause identified several contributing factors to the reported condition: 1.Mold tool age and wear 2.Partial blocking of the cooling system for a specific cavity.These issues may have caused parts to intermittently stick in the cavity not being detected during the mold cycle.This could occur between inspection intervals because of low or random frequency.During production, the processing equipment is checked regularly to verify that the systems are functioning properly.A lot cannot be released unless it passes specification requirements.A corrective and preventative action (capa) has been opened to focus on this complaint and similar processes, to implement horizontal deployment.If information is provided in the future, a supplemental report will be issued.

• Manufacturer (Section D): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer (Section G): COVIDIEN; 1222 sherwood rd; norfolk NE 68701 9062
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6606127
• MDR Text Key: 76679098
• Report Number: 1915484-2017-05031
• Device Sequence Number: 1
• Product Code: LZH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8881160225
• Device Catalogue Number: 8881160225
• Device Lot Number: 703741X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1