MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD SYRINGE CATHETER TIP 50M; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Nonstandard Device (1420)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that the bd syringe catheter tip 50ml had tip breakage.The following information was provided by the initial reporter: material#: 309620 batch#: unknown verbatim: rcc received a complaint via email.Email(s) attached injuries or adverse event: no item: 309620 quantity affected: (b)(4).Serial/lot number:.Po: (b)(6).Are any samples available for return? yes.Reported issue: 50 ml luer lock syringe tip broke off in ecmo cannula connector piece, unable to screw dead-end cap back on connector piece d/t tip being stuck inside.Had to cut into circuit and place a new connector in order to re-establish flows to the patient and circuit.
Additional Manufacturer Narrative
(b)(4) follow up it was reported the syringe tip broke off in an ecmo cannula connector piece.Due to the absence of a physical sample, photographic evidence, or lot number, our quality engineering team was unable to conduct a comprehensive investigation.Current quality controls are in place to identify such defects during the production process.Based on the limited investigation, the cause of the reported incident remains undetermined.If you encounter any further issues with our product, we would appreciate the opportunity to perform a thorough analysis.Examination of the involved product may provide insights into the cause of the reported failure.

• Brand Name: BD SYRINGE CATHETER TIP 50M
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23518550
• Report Number: 1911916-2025-00733
• Device Sequence Number: 18568009
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: (01)00382903096206
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/19/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: 309620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/21/2025
• Supplement Date Received by Manufacturer: 11/19/2025
• Initial Report FDA Received Date: 11/10/2025
• Supplement Report FDA Received Date: 11/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown