MAUDE Adverse Event Report: MITG - KENMEX ARGYLE; MOUTHPIECE, SALIVA EJECTOR

Model Number 8881450004

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/07/2017

Event Type  malfunction  

Manufacturer Narrative

Submit date: 11/22/2017.An investigation is currently under way; upon completion the results will be forwarded.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the cap came off and it go into patient throat and was removed with no complications reported.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

One sample with unknown lot number was received for evaluation.After performing an inspection, the reported issue of a tip detachment and one crack in the saliva ejector was verified.Dimensional inspections were performed according to the specifications for the tubing with the following results: od, specification 0.245 min to 0.255 max with actual reading of 0.249, id, specification 0.155 min to 0.165 max with actual reading of 0.160: with acceptable results.A review of the device history record could not be conducted because a lot number was not provided.A fishbone analysis was performed with a 6ms and multifunctional team comprised by quality, manufacturing engineering, maintenance engineer and operation (production) available information.The manufacturing process was reviewed during a walkthrough the process.The investigation included analyzing the performance of the mold, machine and process.According to the analysis the reported condition of a broken part was performed using the actual condition of the sample; with this we can conclude that the most potential root cause indicates this condition could occur during molding process of tip.The following conditions were found: tool with ejector plate damaged (worn out) unbalance fill in tool unbalance fill in tool runner unbalance formal investigation actions being taken to address the reported condition will be implemented to eliminate the root cause include: 1.-tool repair according to work order 2.-qa alert and notification to personnel regarding this issue to heighten awareness.If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARGYLE
• Type of Device: MOUTHPIECE, SALIVA EJECTOR
• Manufacturer (Section D): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer (Section G): MITG - KENMEX; calle 9 sur no. 1113 cuidad; tijuana,na 22444 ; MX 22444
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7053435
• MDR Text Key: 93197877
• Report Number: 9612030-2017-05245
• Device Sequence Number: 1
• Product Code: DYN
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881450004
• Device Catalogue Number: 8881450004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1