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

Catalog Number	306499
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material#: 306499.Batch number#: unknown.Verbatim#: i received notice that this product is causing an allergic reaction to a patient.Is questioning the sterility of product syringe flsh posiflush 10ml sal prefl plng rod 30/bx product # 0723306553.Patient harm? (b)(6) hospital declined to complete.
Additional Manufacturer Narrative
(b)(4) follow up as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.There are current quality controls in place to detect this type of defect during the production process.Based on the limited investigation results, a cause for the reported incident could not be determined.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.
Event or Problem Description
No additional information received.

• 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: 21218720
• Report Number: 1911916-2025-00040
• Device Sequence Number: 3480282
• Product Code: NGT
• UDI-Device Identifier: 30382903064992
• UDI-Public: (01)30382903064992
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K161552
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 01/23/2025
• Supplement Report FDA Received Date: 02/13/2025
• 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