MAUDE Adverse Event Report: APPLIED MEDICAL C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX; FHF

Model Number C6001

Device Problems Kinked (1339); Aspiration Issue (2883)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

No product is being returned for evaluation and no lot # has been provided to manufacturer.A follow-up report will be sent once the results have been analyzed.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when the initial report was submitted, then the supplemental report will be submitted to the fda.

Event Description

Procedure performed unknown."no, specific lot number, just an overall remark compared to his habitual used system, of conmed: due to flexible tubing, at the level of the suction recipient, the tubing get bended and the system doesn't aspirate anymore.It might be due to light hot saline water they use to rinse, but not was always like that.So, tubing of conmed is more stable.Connection blue plastic should be wider, because it's hard to get it plugged on the recipient's connection point.Spikes are very difficult to get in the 1 liter saline bags.It should be a more tapered design, smaller at the tip of the spike and becoming 'wider' to, the end." patient status- perfect.

Manufacturer Narrative

The incident product was not returned for evaluation.In the absence of the subject device, it is difficult to determine the root cause of the incident.A review of the manufacturing records for this lot could not be performed as no lot number was provided.  although the root cause of the incident could not be determined, applied medical will continue to monitor its vigilance system for trends and take appropriate actions as necessary.In accordance to 21 cfr 803.56, if we obtain additional information, which was not known or was not available when this report was submitted, then the supplemental report will be submitted to the fda.

• Brand Name: C6001, 5MMX33CM PROB/VALV DB, G2, 12/BX
• Type of Device: FHF
• Manufacturer (Section D): APPLIED MEDICAL; 22872 avenida empresa; rancho santa margarita CA 92688
• Manufacturer Contact: 22872 avenida empresa; rancho santa margarita, CA 92688 ; 9497138233
• MDR Report Key: 5595880
• MDR Text Key: 43287187
• Report Number: 2027111-2016-00270
• Device Sequence Number: 1
• Product Code: FHF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K003443
• 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
• Report Date: 03/23/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: C6001
• Device Catalogue Number: 101471293
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1