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

Catalog Number	306499
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported that the syringe cracked during the flushing process.To support the investigation, two empty syringe samples¿without packaging flow wraps, or tip caps¿along with two photographs were submitted for evaluation by the quality team.Upon removal of the syringe barrels and visual inspection, the following observations were made: one sample exhibited a crack approximately 1 inch in length, located ¾ inch from the syringe barrel flange.The second sample exhibited a crack approximately 2¼ inches in length, located 1 inch from the syringe barrel flange.The photographs provided correspond to the received samples.No additional defects or imperfections were observed.This type of damage may occur if a jam is present at the filling machine during processing.A review of the device history record for material number 306499, lot 5077095, was conducted.The review did not identify any quality issues during production that could have contributed to the reported condition.No related quality notifications were found, and all manufacturing processes and final inspections were performed in accordance with specification requirements.The samples will be shared with production associates to raise awareness.The returned sample analysis confirms the customer-reported issue.
Additional Manufacturer Narrative
H11 -a device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
Description: cracked syringe event details: material # 306499, batch # 5077095.While attempting to flush a picc line, the flush syringe cracked.All clamps were open.No air got in to line, but it could have.Was there injury? no.

• 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: 22588916
• Report Number: 1911916-2025-00539
• Device Sequence Number: 8995420
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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: 07/16/2025
• Supplement Date Received by Manufacturer: 08/07/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/07/2025
• 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