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

Catalog Number	305107
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user pressed the plunger after connecting the syringe to the needle and found a leak in the needle.
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 there was a leak in the needle.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 a needle assembly with no packaging blister or plastic shield.No other information could be obtained from the photo.A device history record review was completed for provided material number 305107, lot 3271795.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.Without the actual physical sample analysis, a probable root cause could not be offered.
Event or Problem Description
No additional information received.
Additional Manufacturer Narrative
(b)(4).Follow up for device evaluation it was reported there was a leak in the needle.To aid in the investigation, one sample with the plastic shield, but with no packaging blister, and one photo was provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was assembled to a syringe with saline solution.The solution expelled with a normal flow; no leakage was observed.The photo shows a needle assembly with no packaging blister or plastic shield.No other information could be obtained from the photo.A device history record review was completed for provided material number 305107, lot 3271795.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.
Event or Problem Description
No additional information received.

• 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: 20732970
• Report Number: 1911916-2024-00822
• Device Sequence Number: 12838171
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076(11)230928(17)281130(10)3271795
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2024

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: 3271795
• 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: 11/06/2024
• Supplement Date Received by Manufacturer: 11/22/2024; 12/19/2024
• Initial Report FDA Received Date: 11/20/2024
• Supplement Report FDA Received Date: 11/26/2024; 12/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown