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

Model Number	8881833310
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2021
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 barrel is cracked; when they are drawing/loading the medication, the medicine spills from the crack in the barrel.No patient injury was reported.
Additional Manufacturer Narrative
Investigation conclusion: the customer reported the barrel was cracked.When medication was drawn/loaded up, medication spilled from the crack in the barrel.There was no patient injury/harm reported.A device history record (dhr) review of the reported lot number (033567) shows evidence that the product was released according to all established procedures and qa documentation.Lot and failure mode trending was reviewed and no related trends were identified.A historical review of complaint data did not identify any previous complaints against the reported lot.A review of maintenance records, both corrective and preventive, and calibration records did not identify any issues related to this product issue.All scheduled maintenance and calibration activities were completed per specification.A review of process and material changes performed did not identify any related changes/deviations related to this reported product issue.Process monitoring data was reviewed for the assembly equipment used during production of the reported lot and no related issues were identified.A review of the machine setup was conducted and revealed no issues.Validation parameter sheets/logs were reviewed and indicated the product equipment/machines ran within their validated parameters.A search of the non-conformance database was performed an did not identify any related non-conformances for this reported lot.One used product and seven (7) photographs were provided for evaluation.Visual inspection of the returned used product confirmed the reported product failure.A risk assessment performed calculated the severity as minor and occurrence as remote; deeming an overall risk of acceptable.Quality controls and validated sampling plans in place during deemed the reported lot acceptable as acceptance criterial was met.On the basis of the investigation results provided, a definitive root cause was not determined.Additional action will not be taken at this time.This complaint will be used for tracking and trending purposes.

• Brand Name: MAGELLAN 3ML SFTY COMBO 23X1
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): COVIDIEN; 2010 east international speedw; deland FL 32724
• MDR Report Key: 11679380
• Report Number: 1017768-2021-00922
• Device Sequence Number: 11487909
• Product Code: FMI
• UDI-Device Identifier: 10884521005815
• UDI-Public: 10884521005815
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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): 08/03/2021

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: 8881833310
• Device Catalogue Number: 8881833310
• Device Lot Number: 033567
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 04/14/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 08/03/2021
• Patient Sequence Number: 1