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

Catalog Number 320121

Device Problem Misconnection (1399)

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

Event Date 04/12/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0147009.Medical device expiration date: 31-may-2025.Device manufacture date: 26-may-2020.Medical device lot #: unknown.Medical device expiration date: unkown.Device manufacture date: unknown.Initial reporter fax #: cpf: (b)(6).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 at least 15 bd ultra-fine¿ short pen needles were not functioning.The following information was provided by the initial reporter: patient stated that in the current batch 15 needles did not "work".They are crooked on the inside that is attached to the lantus insulin pen, that is, the needle does not fit into the pen.She reports that this deviation occurs in practically all the boxes he uses from bd ultra-fine, but she does not have access to the batch, manufacturing and validity information of the previous boxes.The diversion did not cause health damage.

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.

Event Description

It was reported that at least 15 bd ultra-fine¿ short pen needles were not functioning.The following information was provided by the initial reporter: patient stated that in the current batch 15 needles did not "work".They are crooked on the inside that is attached to the lantus insulin pen, that is, the needle does not fit into the pen.She reports that this deviation occurs in practically all the boxes he uses from bd ultra-fine, but she does not have access to the batch, manufacturing and validity information of the previous boxes.The diversion did not cause health damage.

• Brand Name: BD ULTRA-FINE¿ SHORT PEN NEEDLES
• 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: 14282881
• MDR Text Key: 298713877
• Report Number: 9616656-2022-00493
• 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,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/12/2022

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
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320121
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 05/12/2022
• Supplement Dates FDA Received: 05/26/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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