MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 23X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881833310

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem Tissue Damage (2104)

Event Date 10/29/2018

Event Type  Injury  

Manufacturer Narrative

An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer states an employee who received a flu vaccination developed an open wound approximately two weeks post vaccination.The wound was treated with topical and oral antibiotics and has healed.Contamination was found on a needle from the same lot and the customer believes that this same issue may have contributed to the injury.

Manufacturer Narrative

A review of the device history report (dhr) for lot no.822705 indicated the product was released meeting all quality standards.All dhrs are reviewed for accuracy prior to product release.In-process procedures are also in place to prevent nonconforming product in the manufacturing process.This ensures components and finished products meet all quality inspection standards.These controls include, but are not limited to: material verification/certification processes, dimensional specifications, statistical samplings, periodic audits, process inspections, machine maintenance/operation and personnel training and certification.Specifically, samples are inspected for foreign matter and molding flash.The lot met the acceptance criteria and was released.The dhrs for shop order production of the safety needles and molded safety shields concluded visual and physical samples inspected identified no issues.There were no ncrs issued against the shop orders.A review of the entire dhr identified no manufacturing or inspection anomalies.A review of maintenance records (both corrective and preventive) and calibration records showed no issues related to the reported condition.All scheduled maintenance and calibration activities were completed.There were no process or material changes related to the reported condition for this product.Additionally, a review of the machine setup was conducted and revealed no issues.There was one (1) sample (opened) returned with this complaint.The sample consisted of a 3ml syringe with a 23ga x 1¿ magellan safety needle.The sample contained an unknown liquid inside the syringe.The needle was visually examined and had a very thin piece of string flash wrapping around the cannula.The string flash originated from the gate of the safety shield, so it¿s not foreign contamination of the device.The reported condition was observed from the sample provided.The exact root cause of the molding flash could not be determined based on available information.The most likely root cause was due to flash, which is stringy plastic material attached at the molded part's gate (the entrance to the mold cavity) forming when melted plastic resin remains at the injection gate as the two mold halves separate.An issue impact assessment (as known as a health hazard evaluation or health hazard assessment) was conducted for magellan gate strings.The biocompatibility testing report for the magellan safety needles revealed that the product demonstrated no evidence of cytotoxicity, the material has no evidence of potential sensitization, no evidence of hemolysis and no evidence of acute systemic toxicity.The biocompatibility testing report confirms the potential harm is low risk.The overall risk score was ¿low¿ for issue impact assessment.Based on the low risk associated with the issue, no additional corrective action will be taken at this time.The reported customer complaint is confirmed.The most likely root cause of this issue is due to flash.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): COVIDIEN; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 8069322
• MDR Text Key: 127090166
• Report Number: 1017768-2018-00519
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 822705
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other