MAUDE Adverse Event Report: COVIDIEN UNKNOWN NS; SYRINGE

Model Number UNKNOWN NS

Device Problems Crack (1135); Hole In Material (1293)

Patient Problem Exposure to Body Fluids (1745)

Event Type  Injury  

Event Description

It was reported to covidien on (b)(6) 2015 that a customer had an issue with a syringe.The customer reports the syringe was filled with blood, which was obtained from the patient's central line, and was connected to an 18g needle.The customer reports taking off the protective cap and inserting the needle into the blood tube.The customer states normally a tube will automatically pull the blood from the syringe because of the vacuum of the tube.That did not happen.Instead a splutter or splash sound was heard.The customer reports looking at the needle and making sure it was on correctly and trying a new tube.The same thing happened.The nurse had the patient's blood on her.After examining the first needle, there was a crack at that hub.

Manufacturer Narrative

Submit date: 02/02/2015.An investigation is currently underway, upon completion the results will be forwarded.

Manufacturer Narrative

A lot number was not provided with the complaint.A review of the lot history record is not possible without a lot number.Maintenance records (both corrective and preventive) and calibration records cannot be reviewed without a lot number.Process monitoring data and a review of the machine setup cannot be conducted without a known lot number.There were no samples submitted with this complaint.A photograph that shows what appears to be a magellan safety needle was provided.The quality of the photo was not very clear.The reported condition could not be confirmed from the photograph provided.The complaint shall be reopened if a sample is received.The exact root cause of the reported condition could not be determined without an actual sample to examine.The most likely root cause is hub damage during assembly or packaging.Prior to a lot release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.Specifically, samples from each lot of needles are visually examined for defects and physically tested for leaks.Without the actual sample to determine a root cause, a corrective action will not be taken at this time.This information will be utilized for trending purposes to determine the need for corrective actions.The production department will be notified of this incident with a copy of this complaint response.

• Brand Name: UNKNOWN NS
• Type of Device: SYRINGE
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd.; deland FL 32724
• Manufacturer Contact: thom mcnamara ; 15 hampshire street; mansfield, MA 02048 ; 5084524811
• MDR Report Key: 4476747
• MDR Text Key: 5326869
• Report Number: 1017768-2015-00003
• Device Sequence Number: 1
• Product Code: NGT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNKNOWN NS
• Device Catalogue Number: UNKNOWN NS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other