MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD LUER-LOK PRECISIONGLIDE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	309642
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/24/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd syringe 10ml ll w/ndl 21x1 rb barrel was cracked.Verbatim: complaint via email.Email(s) attached syringe placed in heprin pump on 2008t machine.Machine was started with no issues.Within two minutes of starting pt, experienced major blood loss in one pateint and minor in another due to cracked needles/issues with the internal rubber componants of the syringe.Upon further inspection, numerous were cracked/broken/damaged and unuseable.All needles with this lot number were pulled from the floor and placed seperate from useable materials customer response on (b)(6) 2026.The syringes wer cracked and have been sent back already so we aren't able to provide any photos.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Customer response on 18-may-2026.Did either patient require medical intervention due to the "blood loss" patient went to outpatient lab to have hgb checked due to blood loss.Did either patient require a blood transfusion? no.Was syringe replaced and treatment completed? yes.Did pump alarm? or was heparin leaking out of pump when defect was noticed? no machine alarms.Blood was found leaked out of the syringe down the machine.

• Brand Name: BD LUER-LOK PRECISIONGLIDE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 25218565
• Report Number: 1213809-2026-00260
• Device Sequence Number: 10073872
• Product Code: FMF
• UDI-Device Identifier: 00382903096428
• UDI-Public: (01)00382903096428
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/01/2026

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: Health Professional
• Device Catalogue Number: 309642
• Device Lot Number: 5343407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2026
• Supplement Date Received by Manufacturer: Not provided; 06/01/2026
• Initial Report FDA Received Date: 05/19/2026
• Supplement Report FDA Received Date: 05/26/2026; 06/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/09/2025
• 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