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	01/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Material # 305128 lot # 4135785 verbatim: rcc received a complaint via email.Email(s) attached.It is more than 15 needles that we have which remain blocked, the passage of liquid does not do original french: cela fait plus de 15 aiguilles que nous avons qui restent bloquer, le passage du liquide ne ce fait pas.
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 needles are blocked.A device history record review was completed by our quality engineer team for provided material number 305128 and lot number 4135785.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation.It was reported the needles are blocked.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then assembled to a syringe with saline solution.It was not possible to expel the solution; the needle is 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, lot 4135785.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.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.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation: it was reported the needles are blocked.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then assembled to a syringe with saline solution.It was not possible to expel the solution; the needle is clogged.This condition could occur when passing the needle through the stopper vial, when opening the packaging by pushing the hub through the packaging blister top web, or the needle is clogged during manufacturing and is an escape from our inspections.A device history record review was completed for provided material number 305128, lot 4135785.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.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.
Event or Problem Description
No additional information received.

• 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: 21283259
• Report Number: 1911916-2025-00068
• Device Sequence Number: 7830910
• Product Code: FMI
• UDI-Device Identifier: 30382903051282
• UDI-Public: (01)30382903051282(11)240514(17)290531(10)4135785
• 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,Followup,Followup
• Report Date (Section B): 03/12/2025

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: 4135785
• 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: 01/16/2025
• Supplement Date Received by Manufacturer: 02/06/2025; 02/20/2025; Not provided
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 02/05/2025; 02/20/2025; 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown