MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SAFETYGLIDE; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/30/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd syringe 1ml s/t w/ndl 27x1/2 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: material #309623, lot #4303339 and 5038159.Verbatim: rcc received a complaint via email.This lot has already been investigated for sub-category/defect ¿primary packaging- difficult to open¿ under (b)(4).Please confirm that this previous investigation can be used for the following report: (b)(4) - gattex ¿ primary packaging ¿ difficult to open.Bd syringe: plastic dosing syringe (1 ml) with needle attached (27g, 1/2 inch).Bd catalogue: 309623.Bd syringe lot number(s): 4303339 and 5038159.(b)(6) awareness date: 18dec2025.Date of occurrence: unknown.Complaint description: patient reports defective product with administration syringes that come with the gattex ancillary supply kit.Patient reports that they tried to tighten the syringe then pull the cap off but the needle keeps popping off.Patient reports 15 of the syringes in the box are having issues so far.Vial of gattex is ok, patient just having issue with administration needle/ syringes but without those patient cannot inject med.Patient has missed a dose or will miss a dose within 48 hours.It is not recommended for patient to miss doses of gattex as they state that without the med their symptoms increase/ flare.Product: gattex.Country of origin.Sample / photo availability: sample/pictures are not available.Ae: ae reported for missed dose.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.
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
Investigation results: potential root cause for the shield tight defect is associated with the assembly process.Most likely too much pressure was applied when applying the needle to the syringe.The complaint is associated with a known issue for this machine during this timeframe.Quality has previously reviewed, evaluated and investigated this failure mode.The following corrective actions were recently completed.- a quality alert sent out to the plant.Completed: 01/15/2025 - re-education of all associates on this production line to applicable work instruction and video for proper procedure for syringe with needle visual inspection.Completed: 02/20/2025.The complaint was not confirmed, and no capa evaluation was required.This complaint type will continue to be trended within the post-market surveillance process, and any determined escalation will be managed there.
Event or Problem Description
No additional information.

• 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 ; 8473935694
• MDR Report Key: 24101591
• Report Number: 1213809-2026-00013
• Device Sequence Number: 10328213
• Product Code: FMF
• UDI-Device Identifier: 00382903096237
• UDI-Public: (01)00382903096237(10)5038159
• 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: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2026

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: 5038159
• 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: 12/30/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 01/16/2026
• Supplement Report FDA Received Date: 01/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/07/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown