MAUDE Adverse Event Report: AQUABILITI AMUSA FLUSH SYRINGE; SALINE, VASCULAR ACCESS FLUSH

Model Number 2T0806

Device Problems Nonstandard Device (1420); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 04/07/2015

Event Type  malfunction  

Manufacturer Narrative

Syringe plunger tip manufacturer reported occasionally a small shard of metal from the process can become lodged in the material that is injection molded.They indicated several quality checks exist in their production line to catch any plunger tips that have any metal in them, but admit that it is a possible occurrence.Results of chemical (inorganic) analyses under review.

Event Description

Appearance of a growth on the rubber stopper (inside of syringe) and a dark orange-brown saline color.The syringe was not used on a patient and was not removed from its packaging.Upon visual evaluation of the returned syringe it appeared that a small piece of metal was lodged in the plunger tip, which had then corroded with exposure to the saline solution in the syringe thus causing the cloudiness.

Manufacturer Narrative

To evaluate any health concerns regarding the cloudiness in the saline solution observed in the reported product, aquabiliti contracted integrated analytical laboratories llc (ial) to conduct inorganic test of the solutions from the cloudy syringe.Aquabiliti also sent a retained sample from lot kh040162 to be likewise tested as a control sample.The conclusion is that the allowable limits, based on mg/kg body weight, demonstrate that all patients and body masses have tolerable intake (ti) levels well above the exposure levels of the inorganic reported in the ial report.Both repeated and long-term use of the reported device, including pediatric and neonate populations, would be considered reasonably safe without significant toxicological concerns.Allowable limits were calculated in accordance with the methods described in ansi/aami/iso 10993-17:2002 biological evaluation of medical devices-part 17: methods for the establishment of allowable limits for leachable substances.

• Brand Name: AMUSA FLUSH SYRINGE
• Type of Device: SALINE, VASCULAR ACCESS FLUSH
• Manufacturer (Section D): AQUABILITI; 5209 linbar dr; ste 640; nashville TN 37211
• Manufacturer Contact: john beasley ; 5209 linbar dr; ste 640; nashville, TN 37211 ; 6158332633
• MDR Report Key: 5783902
• MDR Text Key: 50074027
• Report Number: 1000151124-2016-00001
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• PMA/PMN Number: K111034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2016
• Device Model Number: 2T0806
• Device Catalogue Number: 2T0806
• Device Lot Number: KH04162
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/07/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/21/2014
• 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
• Patient Outcome(s): Other