MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30X1 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305128
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material # 305128 batch # 3055909 it was reported by customer that the needle itself broke off from the hub and became embedded within the patient.Reported issue: we unfortunately encountered a significant product malfunction yesterday that caused a patient safety issue.My partner, xxxx (cc'd on this email), was performing an injection on a patient using a becton- dickinson 30g 1-inch needle from our 8/9/24 order - (b)(4) conservatively estimating, he has performed hundreds of injections using this size needle over the past 7 years.During the injection, the needle itself broke off from the hub and became embedded within the patient.The patient had to be sent to the emergency room for an excision and removal of the needle.We need to file an incident report with the manufacturer regarding this.We would also like to return the remaining needles and receive a refund on this produce.Customer response on september 13, 2024 1.Can you please provide an exact date of event in format mm-dd-yyyy? --> 09-04-2024 2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Also, could you please describe and include any medical intervention required including diagnostics, procedures, and treatment done to remove the needle? --> the needle broke off from the hub during an in-office injection and was embedded within the patient, deep to the skin surface.The patient was referred to a nearby hospital (er) to have the needle removed.At the er, an x-ray was completed.Additional diagnostic ultrasounds were performed at the hospital to identify the needle's location.At the er, the needle was ultimately extracted via an incision and blunt dissection.The incision/dissection site required suturing afterwards and the patient was administered oral antibiotics.
Event or Problem Description
No additional information received.Material # 305128.Batch # 3055909.It was reported by customer that the needle itself broke off from the hub and became embedded within the patient.Verbatim: rcc received a complaint via email.Date: (b)(6) 2024.Complaint number: (b)(4).Account name: (b)(6).Contact person: (b)(6).Item description: needle,spclty hypo,30gx1",rg bvl,stl.Incident description: needle broke off and embedded.Injuries or adverse event: no.Item: 305128.Quantity affected: 1 ea.Serial/lot number: (b)(6).Po : (b)(6).Are any samples available for return? yes.Reported issue: we unfortunately encountered a significant product malfunction yesterday that caused a patient safety issue.My partner, (b)(6) (cc'd on this email), was performing an injection on a patient using a becton- dickinson 30g 1-inch needle from our (b)(6) 2024 order - (b)(6) conservatively estimating, he has performed hundreds of injections using this size needle over the past 7 years.During the injection, the needle itself broke off from the hub and became embedded within the patient.The patient had to be sent to the emergency room for an excision and removal of the needle.We need to file an incident report with the manufacturer regarding this.We would also like to return the remaining needles and receive a refund on this produce.Customer response on (b)(6) 2024.1.Can you please provide an exact date of event in format mm-dd-yyyy? --> 09-04-2024.2.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.Also, could you please describe and include any medical intervention required including diagnostics, procedures, and treatment done to remove the needle? the needle broke off from the hub during an in-office injection and was embedded within the patient, deep to the skin surface.The patient was referred to a nearby hospital (er) to have the needle removed.At the er, an x-ray was completed.Additional diagnostic ultrasounds were performed at the hospital to identify the needle's location.At the er, the needle was ultimately extracted via an incision and blunt dissection.The incision/dissection site required suturing afterwards and the patient was administered oral antibiotics.3.Was there any leak? --> not sure i understand this question.There did not appear to be any fluid/injectate leaking from the needle prior to starting the injection.As the injection was being performed, the needle fully broke off from its hub.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needle broke off from the hub and became embedded within the patient.To aid in the investigation, six samples in sealed packaging blisters were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested for cannula pull.The results were within specification.A device history record review was completed for provided material number 305128, lot 3055909.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: NEEDLE 30X1 RB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20246868
• Report Number: 1911916-2024-00681
• Device Sequence Number: 17970020
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282(11)230224(17)280430(10)3055909
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 305128
• Device Lot Number: 3055909
• 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: 09/13/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown