MAUDE Adverse Event Report: COVIDIEN MAGELLAN SFTY NDLE 22X1-1/2 BULK NONST; SAFETY NEEDLE

Model Number 7777850215

Device Problems Crack (1135); Leak/Splash (1354)

Patient Problem No Code Available (3191)

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

An investigation is currently underway; upon completion, the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a safety needle.The customer states we received the complaint from the market described: nurse inserted the syringe in patient's skin, but the medicine did not get in the needle, overflowed on patient's skin�field sample inspection revealed that black grey needle hub was cracked causing leakage.Medication used: invega sustenna 1x100 mg (b)(4) during injection the medication into the patient.No information in regards to medical intervention.

Manufacturer Narrative

The device history record (dhr) for the reported lot indicates that there were no non-conformance reports issued for this lot.There were no samples submitted with this complaint.The reported condition could not be confirmed without an actual sample to evaluate.An investigation of the reported condition was performed.A review of maintenance records (both corrective and preventive) and calibration records were reviewed and there were no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.A review of process monitoring data was conducted and there were no issues related to the reported condition.A review of the machine setup was conducted and there were no issues.The equipment was reviewed for malfunctions that could cause the reported condition.There were no issues identified with the operation of the equipment during the review.There was 1 sample (opened, hub cavity id (b)(6), no packaging) submitted with this complaint.The sample was cracked at the luer of the hub and the lugs of the hub were damaged from what appeared to be forcible attachment of the device.The reported condition is confirmed.The cause analysis determined the most likely root cause may be attributed to over-torquing of the needle during onto a more rigid coc syringe during the assembly process by the user.Prior to a lot¿s 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 are inspected for hub leaks and damage.The lot met all defined acceptance criteria and was released.Based on the information available, a corrective and preventive action (capa) is not necessary at this time.The investigation did not identify a systemic issue with the product or process.It is recommended the user consults the instructions for use for guidance when attaching the device.

• Brand Name: MAGELLAN SFTY NDLE 22X1-1/2 BULK NONST
• Type of Device: SAFETY NEEDLE
• Manufacturer (Section D): COVIDIEN; 2010 east international speedway blvd.; deland FL 32720
• Manufacturer (Section G): COVIDIEN; 2010 east international speedway blvd; deland FL 32720
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084824151
• MDR Report Key: 6072856
• MDR Text Key: 59331748
• Report Number: 1017768-2016-00097
• Device Sequence Number: 1
• Product Code: BSP
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7777850215
• Device Catalogue Number: 7777850215
• Device Lot Number: 430088X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/04/2016
• Initial Date FDA Received: 11/02/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/08/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1