MAUDE Adverse Event Report: EMBECTA MEDICAL I LLC BD SAFETYGLIDE SYRINGE; SYRINGE, PISTON

Catalog Number	303327
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe safetyglide 1ml w/ndl 27x3/8 ib had leakage.The following information was provided by the initial reporter: material # 303327.Batch # 3100484j1.Verbatim: rcc received a complaint via email.Item description: safetyglide tb syr-needle.Vndr item#: 30332, lot#: 3100484j1, quantity: 1, uom: 100/bx, cmt: leaking, adtl.Cmts: exp - 04/30/28.
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
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(6) follow up report for correction.Initial mdr was filed in error, pr (b)(6) will be cancelled.

• Brand Name: BD SAFETYGLIDE SYRINGE
• Common Device Name: SYRINGE, PISTON
• Manufacturer (Section D): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): EMBECTA MEDICAL I LLC; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22962229
• Report Number: 2243072-2025-01079
• Device Sequence Number: 9520023
• Product Code: FMF
• UDI-Device Identifier: 00382903033270
• UDI-Public: (01)00382903033270
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 09/18/2025

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: Other
• Device Catalogue Number: 303327
• Device Lot Number: 3100484J1
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: 09/18/2025
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/19/2025
• 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