MAUDE Adverse Event Report: CARDINAL HEALTH, INC. MAGELLAN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	8881850215
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that on a couple of needles the top plastic cracked when they were twisted.These were items that their surgery department was using so they are concerned about small pieces getting into the wrong places.Additional information provided on 12sep2023 clarified that the hub cracked.
Additional Manufacturer Narrative
An investigation is currently underway.Upon completion, the results will be forwarded.
Additional Manufacturer Narrative
The following sections were updated or answered: d1 brand name;  d3 manufacturer name and address;  d4 unique identifier (udi) #;  d4 expiration date #;  g4 pma/510(k)number;  h6 evaluation codes.Investigation summary: the device history record was reviewed and indicated that the product was released accomplishing all quality standards.One used sample were returned.A visual inspection was conducted to verify for a cracked hub.The reported issue was confirmed.However, based on the available information, a specific root cause could not be identified.A corrective and preventive action (capa) is not applicable at this time.All information received will be used for further tracking and trending purposes.

• Brand Name: MAGELLAN
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): CARDINAL HEALTH, INC.; 3651 birchwood drive; waukegan IL 60085
• 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: 17760582
• Report Number: 1017768-2023-01090
• Device Sequence Number: 20606644
• Product Code: FMI
• UDI-Device Identifier: 10884521000087
• UDI-Public: (01)10884521000087(17)271130(10)22M247
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Initial Reporter Country: US
• PMA/510(K) Number: K012736
• 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): 09/26/2024

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: 8881850215
• Device Catalogue Number: 8881850215
• Device Lot Number: 22M247
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/15/2023
• Supplement Report FDA Received Date: 09/26/2024
• 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