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
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
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 # 2355084h1.Verbatim: rcc received a complaint via email.Email(s) attached.Item description: safetyglide tb syr-needle vndr item#: 303327.Lot#: 2355084h1.Quantity: (b)(4).Uom: (b)(4)/bx.Cmt: leaking.Adtl.Cmts: exp - 04/30/2028.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.Initial mdr was filed in error, (b)(4) will be cancelled.
Event or Problem Description
No additional information was provided.

• 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: 22962198
• Report Number: 2243072-2025-01080
• Device Sequence Number: 8404324
• 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: 2355084H1
• 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