MAUDE Adverse Event Report: CARDINAL HEALTH MAGELLAN 3MLSFTY COMB 21X1 1/2; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881833115
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Unspecified Mental, Emotional or Behavioural Problem (4430)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Event or Problem Description
The customer reported that the hub cracked during direct patient care while administering antipsychotic injections.The patient received an unknown amount of medication (haldol).As the haldol was being administered it leaked quite a bit and they were not able to gauge how much was actually administered.The patient reported some psychotic symptoms in between injection time frames and had to be supplemented with oral antipsychotics until the next injection was due.No additional medical interventions were required.
Additional Manufacturer Narrative
Ten unused samples and eight photos were provided for evaluation.All samples were visually and physically tested for hub issues and no failures were found.The reported condition could not be confirmed, and an exact root cause of the reported condition could not be determined.The device history record (dhr) was reviewed.During the manufacturing process products were visually inspected and physically tested with no failures found.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 in the 12 months prior to the production date.The oee data for the assembly machines were reviewed for all related the production dates and no equipment issues related to the reported condition were observed.A review of the machine setup was conducted and revealed no issues.The equipment was reviewed for malfunctions or issues that could have contributed to the reported condition, but no such issues were observed during the review.A search of the non-conformance database was conducted for potential issues related to the reported condition.There were no ncrs issued against this lot or shield sub lots for related failure.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 issues with the hub.The shop orders used for this lot met all defined acceptance requirements and were released.There were no anomalies found during a review of the device history record, maintenance records or process monitoring data.There was no evidence of any systemic failure of the manufacturing process.Based on the investigation and root cause analysis, the initiation of a corrective action is not required at this time.This information will be utilized for trending purposes to determine the need for corrective actions.

• Brand Name: MAGELLAN 3MLSFTY COMB 21X1 1/2
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer (Section G): CARDINAL HEALTH; 2010 east international speedw; deland FL 32724
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12819940
• Report Number: 1017768-2021-00991
• Device Sequence Number: 4869398
• Product Code: FMI
• UDI-Device Identifier: 50192253024706
• UDI-Public: 50192253024706
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 8881833115
• Device Catalogue Number: 8881833115
• Device Lot Number: 035729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/22/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 11/16/2021
• Supplement Report FDA Received Date: 02/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown