MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	304387
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 304387 batch number#: 3012230.It was reported that the bd needle safetyglide 23x1-1/2 rb tw needle broke.The following information was provided by the initial reporter: rcc received a complaint via email.Email(s) attached surgeon inserted hypo needle into patient's chest to inject local for surgical incision.When he inserted the hypo, the needle broke off while using it on the patient.Needle and other pieces were removed and none left inside patient.(bf304387) lot number - 3012230.Please review the case information below for a customer reported complaint for one of your products.There is a sample available.Complaint number, created date, event date, manufacturing site, product malfunction/failure mode.Product description summary: complaint quantity sample available resource component # mfg.Sku number component name investigated component lot number was there an injury was there a death case (b)(4).On (b)(6) 2024 broke surgeon inserted hypo needle into patient's chest to inject local for surgical incision.When he inserted the hypo, the needle broke off while using it on the patient.Needle and other pieces were removed and none left inside patient.(bf304387) 2 yes bf304387~psprms 304387 ndl, hypodermic,23gx1-1/2in, rb, tw, safetyglide, st.3012230 no, no.
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)(4) supplemental mdr - needle broken.Since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.
Event or Problem Description
No additional information was provided.

• Brand Name: BD NEEDLE SAFETYGLIDE 23X1-1/2 RB TW
• 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: 19960407
• Report Number: 1213809-2024-00533
• Device Sequence Number: 7174215
• Product Code: FMI
• UDI-Device Identifier: 30382903043874
• UDI-Public: (01)30382903043874(11)230112(17)271231(10)3012230
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 09/11/2024

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: 304387
• Device Lot Number: 3012230
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/12/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown