MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X1-1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305127
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
This mdr is for the chipped needle hub material #: 305127 batch#: 3083311 it was reported by customer that defective needle concern verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.Bd precision glide needle 25g x 11/2" tw (0.5mm x 40mm) ref (b)(4) beckton, dickinson and company lot 3083311 defective needle concern additional information from email chain: bd precisionglide needle 25g x 11/2" tw (0.5mm x 40mm) ref (b)(4) beckton, dickinson and company lot 3083311 good morning, i was assisting (b)(6) dr.In clinic this afternoon on (b)(6) 2024.He was performing an us guided injection into a patient's foot.We noticed that the needle he had inserted into the patient was leaking medication around the hub instead of through the end of the needle tip.He withdrew the needle and tightened the needle onto the syringe making sure it was firm.He inserted the needle again and pushed the plunger to insert the medication.We then noticed that the liquid was coming out from a small hole on the side of the hub.The medication from the small hole made an audible missing sound.He withdrew the needle and i assisted opening a new needle and placed onto the syringe so that he could complete the procedure.I also noticed a concern last week during a procedure when i opened and dropped the same exact type of needle onto a sterile procedure tray.The needle fell onto the procedure tray and i noticed a very small piece of blue plastic.Upon closer examination; i could see that the blue hub had a chip in it.Fortunately the defective needle was seen prior to use.I believe that both of these needles are from the same lot and wanted to inform you know about the issue.I have copied my nurse manager on this email.Please let us know how you would like to proceed.Both of the defective needles were pulled from the (b)(6) medicine supply closet on the second floor (b)(6).
Additional Manufacturer Narrative
(b)(4) : initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation.It was reported medication was leaking around the hub.To aid in the investigation, five 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 connected to a syringe with saline solution.No leakage was observed.A device history record review was completed for provided material number 305127, lot 3083311.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.
Event or Problem Description
No additional information received material #: 305127 batch#: 3083311.It was reported by customer that defective needle concern verbatim: complaint received via email(s) attached.Rcc received a complaint via email.Email(s) attached.Bd precisionglide needle 25g x 11/2" tw (0.5mm x 40mm).Ref 305127.Beckton, dickinson and company.Lot 3083311.Defective needle concern.Additional information from email chain: bd precisionglide needle.25g x 11/2" tw (0.5mm x 40mm).Ref 305127.Beckton, dickinson and company.Lot 3083311.Good morning, i was assisting dr.(b)(6) in clinic this afternoon (b)(6) 2024.He was performing an us guided injection into a patient's foot.We noticed that the needle he had inserted into the patient was leaking medication around the hub instead of through the end of the needle tip.He withdrew the needle and tightened the needle onto the syringe making sure it was firm.He inserted the needle again and pushed the plunger to insert the medication.We then noticed that the liquid was coming out from a small hole on the side of the hub.The medication from the small hole made an audible hissing sound.He withdrew the needle and i assisted opening a new needle and placed onto the syringe so that he could complete the procedure.I also noticed a concern last week during a procedure when i opened and dropped the same exact type of needle onto a sterile procedure tray.The needle fell onto the procedure tray and i noticed a very small piece of blue plastic.Upon closer examination; i could see that the blue hub had a chip in it.Fortunately the defective needle was seen prior to use.I believe that both of these needles are from the same lot and wanted to inform you know about the issue.I have copied my nurse manager on this email.Please let us know how you would like to proceed.Both of the defective needles were pulled from the frisco sports medicine supply closet on the second floor #2.153.

• Brand Name: NEEDLE 25X1-1/2 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: 18594866
• Report Number: 1911916-2024-00041
• Device Sequence Number: 20878740
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2024

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: 305127
• Device Lot Number: 3083311
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown