MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 30GA 1/2IN; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305107
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
The product "seems to be covered and requires change (.)" -- describe patient / (hcp) / user impact not reported -- a technovigilance case associated with the use of the product hypodermic probe 30gx1/2 ref.305107, in which we indicate that at the time of use of the medical device the following is observed "it seems to be clogged and requires change (.)".
Event or Problem Description
Additional batch provided: 3144638.
Additional Manufacturer Narrative
Pr (b)(4) - follow up mdr for additional information and device evaluation b4: updated with additional batch information.Device evaluation: it was reported the needle seemed 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 three needle assemblies with no packaging blisters placed on top of a top web from lot 3083959.No other information could be obtained from the photo.Without the actual physical sample analysis, a probable root cause could not be offered.A device history record review was completed for provided material number 305107, lots 3083959 and 3144638.The review did not reveal any detected quality issues during the production of these lots that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Manufacture narrative.

• Brand Name: NEEDLE 30GA 1/2IN
• 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: 18697325
• Report Number: 1911916-2024-00093
• Device Sequence Number: 15543158
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2024

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: 305107
• Device Lot Number: 3144638
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2024
• Supplement Date Received by Manufacturer: 02/05/2024
• Initial Report FDA Received Date: 02/13/2024
• Supplement Report FDA Received Date: 02/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 80 YR
• Patient Sex: Male