MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO FINE¿ + PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320136

Device Problem Misconnection (1399)

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

Event Date 09/04/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone#: unknown.Initial reporter e-mail: unknown.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 that the bd micro fine¿ + pen needle was difficult to operate and attach to the pen.The following information was provided by the initial reporter, translated from japanese: "after removing the tear drop label, i tried to attach the pen needle to the pen but could not attach it properly.".

Event Description

It was reported that the bd micro fine¿ + pen needle was difficult to operate and attach to the pen.The following information was provided by the initial reporter, translated from japanese: "after removing the tear drop label, i tried to attach the pen needle to the pen but could not attach it properly.".

Manufacturer Narrative

H6: investigation summary: one open 32g x 4mm pen needle sample and one photo was returned from lot.No.1285763, cat.No.320136.Visual examination was carried out on the returned sample and photo and an extra loose cannula was observed on the hub.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.The most likely root cause is due to an incorrect gap between the reversing wheel and cannula wheel during the assembly process.

• Brand Name: BD MICRO FINE¿ + PEN 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: 15497345
• MDR Text Key: 306346508
• Report Number: 9616656-2022-01054
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903201365
• UDI-Public: (01)00382903201365
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320136
• Device Lot Number: 1285763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/12/2021
• 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