MAUDE Adverse Event Report: COVIDIEN 27G X 1 1/4 A (ALUM HUB) RP; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881200508
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional 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.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.
Event or Problem Description
The customer reported that the syringes are leaking on the sides.No patient injury was reported.
Additional Manufacturer Narrative
The lot number was provided, and the device history record (dhr) was reviewed indicating that the product was released accomplishing all quality standards.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.A review of the entire dhr showed no manufacturing or inspection anomalies.A search of our complaint database identified no other complaints against this lot number.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.A review of the machine setup was conducted and revealed no issues.A review of the manufacturing equipment was performed as part of this investigation.The review found no issues with the equipment or process related to the reported condition.There were no samples returned for this complaint, so the reported condition could not be confirmed.The exact root cause could not be determined based on available information.The 6m root cause analysis did not identify any issues with the manufacturing process that would have caused this issue.There was one potential root cause identified during the investigation pertaining to the user (attachment method), but there¿s insufficient information to determine whether those factors were the true root cause.The application of the device could not be verified from the available information.The possible root causes identified in this complaint pertain to the user¿s application of the device.It¿s recommended the user consult the instructions for use for more information.Based on the information available, this potential root cause could not be confirmed or discarded from consideration.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 leakage in the fluid pathway.The lot met the acceptance criteria and was released.Since there were no findings related to the reported condition, no corrective actions are required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: 27G X 1 1/4 A (ALUM HUB) RP
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11233526
• Report Number: 1017768-2021-00898
• Device Sequence Number: 17095123
• Product Code: FMI
• UDI-Device Identifier: 30884521008704
• UDI-Public: 30884521008704
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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
• Operator of Device: No Information
• Device Model Number: 8881200508
• Device Catalogue Number: 8881200508
• Device Lot Number: 926003
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/15/2021
• Supplement Date Received by Manufacturer: 01/15/2021
• Initial Report FDA Received Date: 01/26/2021
• Supplement Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1