MAUDE Adverse Event Report: COVIDIEN MAGELLAN 3ML SFTY COMBO 25X1; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number 8881833510

Device Problems Device Markings/Labelling Problem (2911); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

The incident sample has been requested but to date has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained a follow-up report will be submitted.

Event Description

The customer reports: there is a glue on some of the needles as well as poor measurement markings on the syringe.

Manufacturer Narrative

No lot number was provided.A review of the device history report (dhr) was unable to be performed.However, 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.No physical samples were provided for evaluation.However, photographic images of the sample were submitted with the complaint.The first image showed a 25ga magellan safety needle with a very thin piece of string flash extending from the gate of the safety shield and wrapping around the needle.This was not "glue" as referenced by the customer, but the condition was observed.The second image showed a 3ml syringe with partial and illegible print.The print issue was observed within the photograph.A root cause analysis could not identify a root cause for the poor print issue since the complaint file contains insufficient information.The customer provided a photo of the sample and the issue of string flash was identified.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 was conducted for magellan.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 identified the potential harm as low risk.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 root cause for poor print was unable to be determined.No probable root cause could be identified.The most likely root cause of the secondary reported issue was determined to be 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.This complaint will be used for trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 25X1
• 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: 8038727
• MDR Text Key: 126154335
• Report Number: 1017768-2018-00515
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/19/2018

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: 8881833510
• Device Catalogue Number: 8881833510
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/19/2018
• Initial Date FDA Received: 11/05/2018
• Supplement Dates Manufacturer Received: 10/19/2018
• Supplement Dates FDA Received: 12/19/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1