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

Catalog Number	305127
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/24/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305127 batch#: 3299707 it was reported by the customer that i have had so many of these needles lately where the cap won¿t come off and some that are clogged so i won¿t get a flash.Is this something that others have complained about? i find myself tossing so many of these.Let me know your thoughts i have had so many of these needles lately where the cap won¿t come off and some that are clogged so i won¿t get a flash.Is this something that others have complained about? i find myself tossing so many of these.Let me know your thoughts 2.Not life threatening, just inconvenient that i cannot use needle or that i inject needle and the hub is blocked so does not return a flash.3.No patient harm - just additional injections but needle is blocked so does not return a flash.
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 Manufacturer Narrative
(b)(4) follow up.It was reported the cap will not come off and some needles are clogged.As a sample was not returned a thorough sample evaluation could not be performed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows two needle assemblies out of their packaging blisters.The packaging blister top webs show the needles assemblies were taken out by pushing the unit through the top web instead of separating the top web from the bottom web.No other information could be obtained from the photo.The needle clogged defect could occur if particles from the pushing the unit through the packaging blister top web induced the clogging condition.A device history record review was completed for provided material number 305127, lot 3299707.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 photo sample analysis the symptom reported by the customer could not be confirmed.
Event or Problem Description
No additional information received.Material#: 305127, batch#: 3299707.It was reported by the customer that i have had so many of these needles lately where the cap won¿t come off and some that are clogged so i won¿t get a flash.Is this something that others have complained about? i find myself tossing so many of these.Let me know your thoughts.Verbatim: i have had so many of these needles lately where the cap won¿t come off and some that are clogged so i won¿t get a flash.Is this something that others have complained about? i find myself tossing so many of these.Let me know your thoughts.Comments 08/05/2024.I have the needles and would be glad to ship them to you - will you send me a package? i started saving the needs that the cap does not come off of - i do not save the needs that don't flash because they are used.How would you like me to send them to you? 1.Date of event: this occurs regularly - several times a week.2.Not life threatening, just inconvenient that i cannot use needle or that i inject needle and the hub is blocked so does not return a flash.3.No patient harm - just additional injections but needle is blocked so does not return a flash.

• 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: 19296738
• Report Number: 1911916-2024-00348
• Device Sequence Number: 6892301
• Product Code: FMI
• UDI-Device Identifier: 30382903051275
• UDI-Public: (01)30382903051275
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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): 06/05/2024

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: 3299707
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 05/13/2024
• Supplement Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/26/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown