MAUDE Adverse Event Report: CARDINAL HEALTH MONOJCT 20ML SYR L-SLIP RP; SYRINGE, PISTON

Model Number	881520673
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
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 there has been an instance where a safety needle and syringe needle has broken while in use, causing blood to come in contact with the nursing staff.No product number or further details were provided.
Event or Problem Description
The customer reported that there has been an instance where a safety needle and syringe needle has broken while in use, causing blood to come in contact with the nursing staff.No product number or further details were provided.On (b)(6) 2024 a photo from the customer was provided for review.The photo appears to show a monoject syringe connected to a bd vacutainer with a possible broken syringe tip, not a broken needle.
Additional Manufacturer Narrative
On (b)(6) 2024 a photo from the customer was provided for review.The photo appears to show a monoject syringe connected to a bd vacutainer with a possible broken syringe tip, not a broken needle.Based on this new information, the following sections were corrected: b5 describe event or problem, b2a product code, g contact office manufacturing site, h6 component code.
Additional Manufacturer Narrative
Sections d1 and d4 were updated with the product information after initial analysis of the customer-provided photograph.
Additional Manufacturer Narrative
Based on the information available to us, we were able to confirm the event, and determined that: after analyzing the customer-provided photo, the luer tip of the syringe barrel appears to have broken off inside a bd vacutainer.A device history record review could not be performed because a lot number was not received.As part of our manufacturing process, all device history records are reviewed and approved by quality, prior to release of product.Although the reported issue of a broken tip can be confirmed from the photograph, it cannot be confirmed with certainty to be a manufacturing related defect.An exact root cause was unable to be determined.All information received will be used for further tracking and trending purposes.

• Brand Name: MONOJCT 20ML SYR L-SLIP RP
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): CARDINAL HEALTH; 777 west street; mansfield MA 02048
• Manufacturer (Section G): CARDINAL HEALTH; 1222 sherwood rd; norfolk NE 68701
• Manufacturer Contact: jill saraiva ; 777 west street; mansfield, MA 02048 ; 5086183640
• MDR Report Key: 19191646
• Report Number: 1017768-2024-00041
• Device Sequence Number: 20448993
• Product Code: FMF
• UDI-Device Identifier: 20884521012179
• UDI-Public: 20884521012179
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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,Followup,Followup
• Report Date (Section B): 05/31/2024
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 881520673
• Device Catalogue Number: 881520673
• 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: 03/28/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/26/2024
• Supplement Report FDA Received Date: 05/07/2024; 05/15/2024; 05/31/2024
• 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