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

Catalog Number	305128
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/24/2024
Type of Reportable Event	Malfunction
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.Additional batch reported: batch: (b)(4).Batch creation date: (b)(6) 2024.Batch expiration date: (b)(6).2029 full udi: (b)(4).
Event or Problem Description
Material #: (b)(4).Batch#: (b)(4), (b)(4).It was reported by customer that these needles are used by a physician who runs a pain clinic here at our facility and he has indicated that some of them are obstructed.On average he uses approximately 60 per week and of those, he is reporting that 2-3 are usually obstructed.He has been using these needles for several years now and has never had any problems until this spring.
Event or Problem Description
Additional information received 1.What was the impact to the patient? after needle insertion, it was not possible to complete the injections so the needle had to be removed and a second injection done at the same site with an unobstructed needle.2.Did the issue happen during patient use? if yes, was there any injury? if so, please describe and include any medical treatment needed as a result? the issue did not occur when the patient was using the needle.I was doing an injection.The injury was requirement to do a second needle puncture as the first needle was obstructed.3.Any adverse event or serious injury reported to patient or healthcare professional? if yes, please provide the details.There were no serious injuries.7.Were you able to draw up solution and then unable to expel? it was not possible to move any fluid through the needles either by pulling back on the plunger or pressing on it.8.Is there any visible blockage? as you know, doubt no, these needles are tiny.No obstruction is visible.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported some needles are obstructed.To aid in the investigation, four samples with no 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 assembled to a syringe with saline solution.It was not possible to expel the solution; these needles are clogged.It could be possible for this defect to occur while passing the needle through the stopper vial clogging the needle with the stopper vial material.A device history record review was completed for provided material number 305128, lots 4135785 and 3083963.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.There are quality controls currently in place to detect this type of defect during the production process such as a vision system that inspects 100% of all products for clogged needles.Based on the investigation and with the returned sample analysis the symptom reported by the customer is 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: 20383273
• Report Number: 1911916-2024-00715
• Device Sequence Number: 8037844
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282(11)230324(17)280531(10)3083963
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• 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): 10/24/2024

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: 305128
• Device Lot Number: 3083963
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/07/2024
• Supplement Report FDA Received Date: 10/24/2024
• 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