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

Model Number	8881850510
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Type of Reportable Event	Malfunction
Event or Problem Description
The customer sent two photos, one that appears to show a bent needle coming out under the sheath and another photo that appears to show a small amount of blood on a thumb.They stated that they have had numerous occasions like this and that they would like to be able to go back to the old needles they used so they can cut down on needle sticks.They used to use bd eclipse needles and did not have this issue.Additional information received on 20oct2023 stated that there have been multiple times where the needles just bend and break when trying to draw up meds.One person has been stuck (pre patient) 3-4 times.The needles also do not always latch to the syringe and as they are injecting the patient, and they can see the medication dripping out from that point, so the patient is not getting the full dose.The doctor uses these for steroid injections and is worried about how easily they bend when he is doing joint injections.Some needles are just pointing directly sideways when they are first opened.
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: based on the information available to us, we were able to confirm the event and determined that although the 50 unopened samples returned for evaluation passed the visual and functional tests, the reported condition was confirmed through the photos provided.The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The product was manufactured between (b)(6) 2023 and (b)(6) 2023.The exact root cause could not be determined with the available information.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: 18070155
• Report Number: 1017768-2023-01099
• Device Sequence Number: 7594252
• Product Code: FMI
• UDI-Device Identifier: 10884521000568
• UDI-Public: (01)10884521000568(17)280630(10)S14691
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 09/24/2024

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: 8881850510
• Device Catalogue Number: 8881850510
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/18/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/03/2023
• Supplement Report FDA Received Date: 09/24/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown