MAUDE Adverse Event Report: CARDINAL HEALTH 3 GA ROTOR HINGED LID - T RED; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8527R
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
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.
Event or Problem Description
The customer reported that they received cracked lids.There was no damage to the shipping box and no injuries occurred.
Additional Manufacturer Narrative
The device history record (dhr) review concluded no abnormal process conditions were present during the manufacturing of this product that would lead to the reported condition.The sample analysis of the returned device confirmed the crack in the lid.The crack is near the handle on the side of the lid with the rotor opening.The root cause investigation could not determine a specific root cause as the condition could occur with pulling up on the lid after it¿s been locked.The crack is on the non-hinged side.Therefore, it¿s possible that the user locked the lid and then tried to remove the lid or as a result of transportation of the product or repackaging of the product.At this time however, there is no additional evidence to make a definitive root cause.A corrective/preventative action is not deemed necessary based on reported condition¿s risk to patient/user and trending.The issue will be monitored through routine complaint trend analysis and reviewed by capa review board (crb) for capa as necessary.

• Brand Name: 3 GA ROTOR HINGED LID - T RED
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer (Section G): CARDINAL HEALTH; 815 tek drive; crystal lake IL 60039 9002
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 12599214
• Report Number: 1424643-2021-00619
• Device Sequence Number: 11768202
• Product Code: FMI
• UDI-Device Identifier: 40884521018304
• UDI-Public: 40884521018304
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2021

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
• Device Model Number: 8527R
• Device Catalogue Number: 8527R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/06/2021
• Supplement Date Received by Manufacturer: 10/06/2021
• Initial Report FDA Received Date: 10/08/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown