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	07/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material #: 304387.Batch#: 3040029.It was reported that the bd needle safetyglide 23x1-1/2 rb tw needle broke.The following information was provided by the initial reporter: verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.Needle broke off at hub when removing item#304387.The customer advised that the patient was being administered euflexxa, the pa administered the injection and as the needle was being removed from the patients knee, the needle broke off of the hub.The needle was almost out and the pa was able to safely remove the needle with no injury to the patient.
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
No additional information was provided.
Additional Manufacturer Narrative
Pr (b)(4).Follow up mdr for device evaluation.Three hundred fifty samples were provided to our quality team for investigation.Three hundred forty-nine samples were received in sealed packaging blisters and one sample received with no packaging blister and plastic shield.One hundred twenty-five samples were randomly selected for investigation.A visual inspection was performed with a 30x magnification, and no defects or imperfections were observed.The safety mechanism was activated with no issues of loose/broken needle.The sample received with no packaging blister has no needle and the needle hub has no residue of epoxy.Based on the investigation with the sample analysis the symptom reported is confirmed.This defect could occur during the assembly process if there was a misfeeding of the cannulator.Furthermore, a device history record review was completed for provided lot number 3040029.A review showed no rejected inspections or quality issues during the production that could have contributed to the reported defect.The settings were correct, and the flow of product was good.

• 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: 20294104
• Report Number: 1213809-2024-00655
• Device Sequence Number: 7996535
• Product Code: FMI
• UDI-Device Identifier: 30382903043874
• UDI-Public: (01)30382903043874(11)230209(17)280131(10)3040029
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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
• Report Date (Section B): 10/03/2024

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: 3040029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/03/2024
• Initial Report FDA Received Date: 09/24/2024
• Supplement Report FDA Received Date: 10/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown