MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 25 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850510

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Date 11/14/2018

Event Type  malfunction  

Event Description

Customer reports: there was plastic fiber around the needles of 17 each.The issue was found during inspection prior to use.The exact lot is unknown because two lots, 821923 and 820100, were mixed together prior to the inspection.

Manufacturer Narrative

The device history records (dhrs) for lot numbers 820100 and 821923 indicates product and specification requirements were met with no non-conforming product identified relating to this customer report.A lot cannot be released unless it passes all quality and conformance requirements.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.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 was no process or material changes related to the reported condition.A review of the machine setup was conducted and revealed no issues.A review of the entire dhr for all lot numbers identified no manufacturing or inspection anomalies.The shop orders for the safety needles assembled for this lot were also reviewed.There were no ncrs issued against any of the shop orders and no issues reported pertaining to product visual/physical inspections.There were also no ncrs issued against the shop orders of the molded safety shields utilized in production of the product.The same lot numbers and reported issue were previously investigated.Therefore, existing investigations were utilized to satisfy this investigation/reporting.There were seventeen (17) needle assemblies and one (1) empty unit package (opened) returned with this complaint.The unit package was labeled with item number 8881850510, lot 821923.There was no other labeling provided with this complaint.All needles were 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 safety shields were examined and were imprinted with an indicator that traces to twelve (12) different cavities from mold number 823.There were three (3) subsequent samples (opened) received and evaluated.One (1) sample was from lot number 820100, a second was from lot number 821923 and a third was from an unknown lot number (potentially 820844).All samples were 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 safety shield from lot 820100 was examined and was imprinted with an indicator that traces to mold number 824.The safety shield from lot 821923 was examined and was imprinted with an indicator that traces to mold number 823.The safety shield from the unknown lot was examined and was imprinted with an indicator that traces to mold number 823.The reported condition was observed within the samples.The exact root cause of the molding flash could not be determined based on available information.The customer provided a photo of the sample and the defect of string flash was identified upon photo review.The most probable 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: SAFETY NEEDLE 25 X 1
• 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: jill saraiva ; 15 hampshire street; mansfield, MA 02048 ; 5084524970
• MDR Report Key: 8130786
• MDR Text Key: 129315396
• Report Number: 1017768-2018-00529
• 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: 02/06/2019

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: No Information
• Device Model Number: 8881850510
• Device Catalogue Number: 8881850510
• Device Lot Number: 821923,820100
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/14/2018
• Initial Date FDA Received: 12/04/2018
• Supplement Dates Manufacturer Received: 11/14/2018
• Supplement Dates FDA Received: 02/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1