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 # 100484f1.Verbatim: rcc received a complaint via email.Item description: safetyglide tb syr-needle, vndr item#: 303327, lot#: 100484f1, 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.
Additional Manufacturer Narrative
(b)(4) follow up report for correction.Lot number was incorrect in the initial mdr, correct lot number is 3100484.
Event or Problem Description
No additional information was provided.
Additional Manufacturer Narrative
Investigation summary: 97 unused needles with syringe (material# 303327 batch # 3100484f) were received and analyzed by our quality team with the customer's complaint of leakage during use.The unused samples were tested by drawing saline solution and injecting it with resistance and there were no leaks in any of the 97 samples.The samples were then analyzed under high power microscope to search for abnormalities and no syringes presented with issues.The complaint could not be verified and the root cause remains unknown without the original affected samples.
Event or Problem Description
Samples.

• 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): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 22967612
• Report Number: 2243072-2025-01090
• Device Sequence Number: 21146533
• 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,Followup
• Report Date (Section B): 01/12/2026

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: 3100484
• 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: 08/14/2025
• Supplement Date Received by Manufacturer: Not provided; 01/12/2026
• Initial Report FDA Received Date: 09/04/2025
• Supplement Report FDA Received Date: 09/19/2025; 01/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/10/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown