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

Catalog Number 305107

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f27 ¿ no patient involvement.Device problem code: a0504 - leak / splash.

Event Description

A drug leak in the syringe occurred at the junction between the needle and the hub.The same phenomenon was observed in several products with a specific manufacturing number.

Event Description

(b)(4).No additional information received.A drug leak in the syringe occurred at the junction between the needle and the hub.The same phenomenon was observed in several products with a specific manufacturing number.

Manufacturer Narrative

(b)(4) follow up.It was reported leakage occurred at the junction between the needle and the hub.As a sample was not returned, a thorough sample investigation could not be completed.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows syringes with needle assemblies in a plastic bag with one packaging blister top web.No other information could be obtained from the photo.A device history record review was completed for provided material number 301507, lots 3055908 and 2279767.The review did not reveal any detected quality issues during the production of these lots that could have contributed 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 these lots.Based on the investigation and with the photo sample analysis the symptom reported by the customer could not be confirmed, and without the defective physical sample analysis a probable root cause could not be offered.H3 other text : see h10 narrative.

Event Description

No additional information received.A drug leak in the syringe occurred at the junction between the needle and the hub.The same phenomenon was observed in several products with a specific manufacturing number.

Manufacturer Narrative

(b)(4) follow up for device evaluation: it was reported leakage occurred at the junction between the needle and the hub.To aid in the investigation, fourteen samples with no packaging blisters were received for evaluation by our quality team.The samples came in two separate sample containers.One sample container was labeled 3055908.This container had five samples; four samples are bd samples, and one sample was of an unknown brand.The four bd samples were visually inspected, and no defects or imperfections were observed in three of the samples.The fourth sample has the needle bent about thirty degrees.Each sample was connected to a syringe with saline solution.No leakage or any other defects were observed.The second sample container was labeled 2279767.This container had nine bd samples with no packaging blisters.A visual inspection was performed, and no defects or imperfections were observed.Each of these samples were connected to a syringe with saline solution, and no leakage or any other defect was observed.The photo shows syringes with needle assemblies in a plastic bag, and one packaging blister top web.No other information could be obtained from the photo.A device history record review was completed for provided material number 301507, lots 3055908 and 2279767.The review did not reveal any detected quality issues during the production of these lots that could have contributed 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 these lots.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: NEEDLE 30GA 1/2IN
• Type of Device: 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 ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18154977
• MDR Text Key: 328373556
• Report Number: 1911916-2023-00847
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K021475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305107
• Device Lot Number: 2279767
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1