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	01/30/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pr (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
Complaint from (b)(6) hospital.The customer complained that after withdrawing drugs through the needle and then injected it to the patient, it was found that the drug was blocked and could not be pushed into the patient.No patient harm.
Event or Problem Description
No additional information received complaint from (b)(6) hospital.The customer complained that after withdrawing drugs through the needle and then injected it to the patient, it was found that the drug was blocked and could not be pushed into the patient.
Additional Manufacturer Narrative
Pr (b)(4) follow up for device evaluation it was reported the drug was blocked and could not be pushed.To aid in the investigation, one sample in an opened packaging blister and two photos were provided for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.It was not possible to expel the solution; the needle is clogged.The photos show a needle assembly out of the packaging blister in a plastic bag.No other information could be obtained from the photos.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 305107, lot 3055908.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.
Additional Manufacturer Narrative
(b)(4).Follow up.It was reported the drug was blocked and could not be pushed.As a sample was not returned, a thorough sample evaluation could not be performed.To aid in the investigation, two photos were provided for evaluation by our quality team.The photos show a needle assembly out of the packaging blister in a plastic bag.No other information could be obtained from the photos.A device history record review was completed for provided material number 305107, lot 3055908.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.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.Complaint from (b)(6) hospital.The customer complained that after withdrawing drugs through the needle and then injected it to the patient, it was found that the drug was blocked and could not be pushed into the patient.

• 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: 18634469
• Report Number: 1911916-2024-00053
• Device Sequence Number: 8092731
• Product Code: FMI
• UDI-Device Identifier: 00382903051076
• UDI-Public: (01)00382903051076
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/02/2024

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: 3055908
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/31/2024
• Supplement Date Received by Manufacturer: 02/16/2024; 03/02/2024
• Initial Report FDA Received Date: 02/02/2024
• Supplement Report FDA Received Date: 02/16/2024; 03/04/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown