MAUDE Adverse Event Report: COVIDIEN SAFETY NEEDLE 18 X 1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881850810

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

The complainant indicated that the device will not be returned for evaluation; therefore, a failure analysis is not available, and we are not able to determine the relationship between this device and the cause for this event.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.If additional information or the sample is received, the investigation will be reopened and responded to accordingly.

Event Description

Customer states: product complaint.Additional information received from the customer states: the needles have plastic at the bottom of the needle.

Manufacturer Narrative

A review of the device history record (dhr) for lot no.820825 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.Specifically, samples are inspected for foreign matter and molding flash.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.There was an ncr (non-conformance record) issued against the lot, but it was for an unrelated condition.A review of the entire dhr identified no manufacturing or inspection anomalies.The shop orders for the production of the safety needles and molded safety shields identified no issues.There were no ncrs issued against the shop orders.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 were no samples submitted with this complaint, but a photograph of the needle was attached to another complaint that was received for the same reported condition.The photograph from that complaint showed a very thin piece of string flash wrapping around the cannula.The reported condition is confirmed based on the sample evaluation from the related complaint.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: SAFETY NEEDLE 18 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: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 7986649
• MDR Text Key: 124527584
• Report Number: 1017768-2018-00512
• 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: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/05/2019

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: Other
• Device Model Number: 8881850810
• Device Catalogue Number: 8881850810
• Device Lot Number: 820825
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2018
• Initial Date FDA Received: 10/19/2018
• Supplement Dates Manufacturer Received: 09/20/2018
• Supplement Dates FDA Received: 02/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1