MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320147

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problems Pain (1994); Skin Inflammation/ Irritation (4545); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/17/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported bd ultra-fine¿ needle had an insufficient cannula length, resulting in leakage.The following information was provided by the initial reporter: ".It was believed that they did not reach the necessary depth, thus leaking medication onto the skin.".

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported bd ultra-fine¿ needle had an insufficient cannula length, resulting in leakage.The following information was provided by the initial reporter: ".It was believed that they did not reach the necessary depth, thus leaking medication onto the skin.".

Event Description

It was reported bd ultra-fine¿ needle had an insufficient cannula length, resulting in leakage.The following information was provided by the initial reporter: ".It was believed that they did not reach the necessary depth, thus leaking medication onto the skin.".

Manufacturer Narrative

Investigation summary: customer returned images of the shelf carton for 5mm, 31 gauge pen needles from lot 9169560.No images of the pen needles themselves were returned.Direct inspection of the samples would be required in order to fully evaluate their condition.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.Based on the images received, bd was unable to confirm the customer¿s indicated failure of leakage.Based on the images received, bd was unable to confirm the customer¿s indicated failure of a dimension discrepancy.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• Brand Name: BD ULTRA-FINE¿ NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13446729
• MDR Text Key: 285165264
• Report Number: 9616656-2022-00100
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320147
• Device Lot Number: 9169560
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/18/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1