MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1-1/4 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305136
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Batch number#: 2265199.It was reported by customer that they have been experiencing issues with the 27g 1 1/4" precision glide needles, lot 2265199, exp.10/31/2027.It is random but some of the needles don't allow any of the drawn-up medications to be administered, it's like there is no opening in the end of the needle.The medications are drawn up using an 18g blunt needle and then we dispose of it and put the 27g needle on.Not sure what to do with these or if you have had any other complaints of the same nature.
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
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needles do not allow any of the drawn-up medications to be administered.To aid in the investigation, two hundred twenty-four samples in sealed packaging blisters and one photo was provided for evaluation by our quality team.One hundred twenty-five samples were randomly selected for investigation.A visual inspection was performed, and no defects or imperfections were observed.Each of the selected samples were then assembled to a syringe with saline solution.The needles expelled the solution with a normal flow.The photo provided shows a packaging shelf box.A device history record review was completed for provided material number 305136, lot 2265199.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 27X1-1/4 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: 20438939
• Report Number: 1911916-2024-00728
• Device Sequence Number: 7990494
• Product Code: FMI
• UDI-Device Identifier: 30382903051367
• UDI-Public: (01)30382903051367(11)220922(17)271031(10)2265199
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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: 305136
• Device Lot Number: 2265199
• 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: 10/07/2024
• Supplement Date Received by Manufacturer: 10/24/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 10/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown