MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SafetyGlide; Piston Syringe

Catalog Number	309623
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 1ml s/t w/ndl 27x1/2 rb needle pulled out of hub.Complaint via email.Awareness date: 25aug2026.Bd 30 day due date: 27sep2026.Product: gattex 5mg patient kit 30ct (gattex 5mg patient kit 30ct).Lot: av26098aa.Component: description: syringe 1ml s/t w/ndl 27x1/2 rb.Bd product no: 309623.Bd lot: 6007437 & 6047370.Complaint description: patient's sister reported that sometimes the needle is not tight.Sometimes it breaks off in the patient's arm when it injects too slowly.Medication comes out slowly from the syringe.No further pertinent details provided.Country of origin: sample / photo availability: none.Follow up performed with no reply.Adverse event (ae): 2026tus108180.Patient identifiers: patient identifiers (e.G., gender, weight, ethnicity) will not be available for this investigation request.Additional information: no additional information is available at this time.Prior investigation reference / assessment: no prior investigation.
Additional Manufacturer Narrative
B3.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.

• Brand Name: BD SafetyGlide
• Common Device Name: Piston Syringe
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; +1(847)393-5694
• MDR Report Key: 50823211
• Report Number: 1213809-2026-00485
• Device Sequence Number: 10210682
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237(11)260107(17)301231(10)6007437
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• 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): 09/25/2026

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: Lay User/Patient
• Device Catalogue Number: 309623
• Device Lot Number: 6007437
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2026
• Supplement Date Received by Manufacturer: 09/25/2026
• Initial Report FDA Received Date: 09/18/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/07/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown