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

Catalog Number 320559

Device Problems Break (1069); Misconnection (1399)

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

Event Date 08/24/2022

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 3 bd micro-fine¿+ pro pen needles were difficult to attach to the pen, and 2 pen needles had broken non-patient ends.The following information was provided by the initial reporter, translated from japanese: "the user's verbatim report is that three pen needles.Can thus not be attached to the pen.Bdj found 2 np needle broken.".

Event Description

It was reported that 3 bd micro-fine¿+ pro pen needles were difficult to attach to the pen, and 2 pen needles had broken non-patient ends.The following information was provided by the initial reporter, translated from japanese: "the user's verbatim report is that three pen needles.Can thus not be attached to the pen.Bdj found 2 np needle broken.".

Manufacturer Narrative

Investigation summary: three open 32g x 4mm pen needle samples and four photos were returned from lot.No.1160323, cat.No.320559.Visual examination was carried out on all three samples and a broken non patient end of cannula was observed on two samples, no issues were observed on the third sample.A functionality test was also carried out on all three samples as per q-sop-183-dl and no issues were observed.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.As all samples returned were open it is not possible to confirm this defect to be manufacturing related.

• Brand Name: BD MICRO-FINE¿+ PRO 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: 15452411
• MDR Text Key: 305706324
• Report Number: 9616656-2022-01009
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205592
• UDI-Public: (01)00382903205592
• 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
• 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: 09/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320559
• Device Lot Number: 1160323
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2021
• 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