MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 25X5/8 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305122
Medical Device Problem Codes	Material Puncture/Hole (1504); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material #:305122.Batch #:3055930.It was reported by the customer that 2 boxes of 100 of needle 25x5/8 rb sterile had liquid leaking out of the hub.Verbatim: please find complaint attached reported to penn vet from (b)(6).The clinic reports 2 boxes of 100 of needle 25x5/8 rb sterile (305122), lot 3055930, exp.4/28 ¿ liquid leaking out of the hub.May have hole in the hub.The po vedco received this product on is 106009.
Additional Manufacturer Narrative
(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a0202 - defective component.Patient problem code: f27 ¿ no patient involvement.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Pr 9061274 additional information received material #: 305122, batch #: 3055930.It was reported by the customer that 2 boxes of 100 of needle 25x5/8 rb sterile had liquid leaking out of the hub.Verbatim: please find complaint attached reported to penn vet from animals r special.The clinic reports 2 boxes of 100 of needle 25x5/8 rb sterile (305122), lot 3055930, exp.4/28 ¿ liquid leaking out of the hub.May have hole in the hub.The po vedco received this product on is 106009.Response received on 16-oct-2023: videos of the situation have been sent separately: 1.Are you able to provide the date of incident? approximately october 9th-12th.2.Please describe how was the issue first noticed.Vaccinating a patient and stocking inventory.3.What procedure was being performed? vaccinating a patient.4.What solution/medication was being used? rabies vaccine.5.Was the procedure completed as planned? we redrew the vaccine and changed out our defective needle and completed the procedure.6.Was there any patient involvement? if so, what was the patient outcome? yes, the patient was not effective.7.Is any sample available for investigation? if no, can a photo be provided? yes, i saved the packages and the defective needle.I also provided video of such as well.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported there may be a hole in the needle hub.To aid in the investigation, one sample with no packaging blister and two videos were provided for evaluation by our quality team.A visual inspection was performed, and there is a molding short shot about 1/4" from the bottom of the needle hub.The sample was then connected to a syringe with saline solution.There was a leak from the molding short shot.The two videos provided show the sample received.No other defects or imperfections were observed.This defect could occur if there was a process variation during the molding process.A device history record review was completed for provided material number 305122, lot 3055930.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.The sample will be shown to associates for awareness.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 is confirmed.

• Brand Name: NEEDLE 25X5/8 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17984443
• Report Number: 1911916-2023-00795
• Device Sequence Number: 8171722
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 10/30/2023

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: 305122
• Device Lot Number: 3055930
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 10/30/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 10/30/2023
• 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
• Patient Sex: Unknown