MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 10ML SHORT PR SALINE 10ML FILL; SALINE, VASCULAR ACCESS FLUSH

Catalog Number	306499
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported cracked syringe.Event description: material#: 306499, batch#: 5077095.Was preparing a trifuse to draw labs and one of the ns flushes cracked down the side and leaked.The device was never connected to the patient.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation a cracked syringe barrel was reported, resulting in leakage.To support the investigation, one empty prefilled syringe¿received without flow wrap packaging or a tip cap¿was submitted to the quality team for evaluation.Upon visual inspection, a crack approximately 2 inches in length was observed, beginning about ¾ inch from the syringe barrel flange.No additional defects or abnormalities were noted.This type of damage is consistent with a potential jam occurring at the filling machine.A device history record (dhr) review was conducted for material number 306499, lot 5077095.The review found no quality issues during production that could have contributed to the reported condition.No related quality notifications were identified.All manufacturing processes and final inspections were performed in accordance with specification requirements.Verification of the filling machine was also completed.The machine settings, barrel feed alignment, and rail positioning were all confirmed to be within acceptable parameters.Product flow was observed to be consistent and uninterrupted.Based on the investigation and analysis of the returned sample, the customer-reported issue has been confirmed.

• Brand Name: SYRINGE 10ML SHORT PR SALINE 10ML FILL
• Common Device Name: SALINE, VASCULAR ACCESS FLUSH
• 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: 22794172
• Report Number: 1911916-2025-00569
• Device Sequence Number: 8808748
• Product Code: NGT
• UDI-Device Identifier: 00382903064991
• UDI-Public: (01)00382903064991(17)280229(10)5077095
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/04/2025

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: 306499
• Device Lot Number: 5077095
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/13/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown