MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE; PISTON SYRINGE

Catalog Number 328512

Device Problems Partial Blockage (1065); Failure to Deliver (2338)

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

Event Date 12/06/2021

Event Type  malfunction  

Event Description

It was reported that 1 bd insulin syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter :   the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown.Samples : available.

Manufacturer Narrative

Date of event: unknown.Medical device expiration date : unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 1/6/2022 h.6.Investigation: customer returned (1) 3/10cc, 8mm, 31g syringe in an open poly bag from lot # 0160001.Customer states that the needle wiill not draw, plunger rod appeared to be blocked and bounced back while drawing.The returned syringe was tested and was able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 0160001.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

Event Description

It was reported that 1 bd insulin syringe with the bd ultra fine¿needle was difficult to prime and inject.The following information was provided by the initial reporter :   the consumer reported that the needle will not draw and stated that the plunger rod appeared to be blocked and bounced back while trying to draw.Date of event : unknown samples : available.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINE¿NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13157642
• MDR Text Key: 284386532
• Report Number: 1920898-2021-01359
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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: 328512
• Device Lot Number: 0160001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2021
• Initial Date FDA Received: 01/04/2022
• Supplement Dates Manufacturer Received: 01/13/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2020
• 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