MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE CATHETER TIP 50ML; SYRINGE, IRRIGATING (NON DENTAL)

Catalog Number	309620
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It is reported foreign matter.Event description: it was reported that next, i send for your socialization the following incident that is presented in the service of central limonar pharmacy with the item: 1000000552 syringe 50ml catheter tip 309620 bd lot: 5043318 (1 und), taking into account the above we are attentive to technical response.
Additional Manufacturer Narrative
(b)(6) follow up.A sealed device was reported to be contaminated.As the physical sample was not returned, a comprehensive evaluation could not be conducted.To support the investigation, a single photograph was provided and reviewed by the quality team.The image depicts a syringe within its blister packaging and a top web.Discoloration is visible at the bottom of the syringe, including the tip, while no other defects or irregularities were observed.A review of the device history record was completed for material number 309620, lot 5043318.The assessment did not identify any quality issues during the production of this lot that could be linked to the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.To date, no similar events have been reported for this lot.Based on the investigation and analysis of the photographic evidence, the reported symptom has been confirmed.However, in the absence of the physical sample, it was not possible to determine a probable root cause.
Event or Problem Description
Additional information received.Has there been any damage to patients or health personnel? no.Could you please confirm the quantities affected? 1.When did this incident occur, before, after or during the procedure? before.

• Brand Name: SYRINGE CATHETER TIP 50ML
• Common Device Name: SYRINGE, IRRIGATING (NON DENTAL)
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• 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: 22904326
• Report Number: 1911916-2025-00622
• Device Sequence Number: 8851346
• Product Code: KYZ
• UDI-Device Identifier: 00382903096206
• UDI-Public: (01)00382903096206(11)250214(17)300131(10)5043318
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2025

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: 5043318
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 10/16/2025
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown