MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 27X1/2 RB; PISTON SYRINGE

Catalog Number	309623
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	08/01/2024
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 needle shielding failure.The following information was provided by the initial reporter: rcc received a complaint via email.Safety for needle cover after insertion did not trigger, resulting in needle being exposed and possible safety risk.Cat# of product being complained: bd309659 description of product: syringe tuberculin l/sl st 1ml disp clr scale 200ea/bx 8bx/ca lot or s/n: (b)(6).Additional information provided: please see pictures of the tb syringe needle with no safety.We have taken all of these syringes off the units to ensure employee safety! the needle went right through the plastic top and injured our employee.It is the bd 1 ml tb syringe ¿ slip tip with bd precisionglide needle 27 g x ½ (0.4mm x 13 mm).
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(6) - supplemental mdr - needle shielding failure.Two photos were provided to our quality team for investigation.One photo shows a packaging blister with the syringe and needle assembly in it and other photo shows packaging blister top web.No defects or imperfections were observed.Please note this product is one single use and should not be recapped after use.Based on the investigation and with the photo sample analysis the symptom reported could not be confirmed.Furthermore, a device history record review was completed for provided lot number 4129992.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 27X1/2 RB
• 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: 20485450
• Report Number: 1213809-2024-00734
• Device Sequence Number: 4105556
• Product Code: FMF
• UDI-Device Identifier: 30382903096597
• UDI-Public: (01)30382903096597
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2025

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: Health Professional
• Device Catalogue Number: 309623
• Device Lot Number: 4129992
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 01/28/2025
• Initial Report FDA Received Date: 10/18/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown