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

Catalog Number 328411

Device Problem Material Separation (1562)

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

Event Date 11/01/2021

Event Type  malfunction  

Event Description

It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had plunger loose issues.The following information was provided by the initial reporter : the consumer reported that when drawing with 1 syringe the stopper came away from plunger rod.Date of event : unknown.Sample status : awaiting sample.

Manufacturer Narrative

Date of event: 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: 11/19/2021.H.6.Investigation: customer returned a single 1.0ml syringe with no polybag for further identification.The syringe¿s black rubber stopper and plunger rod separated from one another when the plunger rod was drawn back, leaving the stopper lodged at the distal tip of the body of the syringe.A review of the device history record was completed for batch# 1047965.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the sample received, bd was able to confirm the customer¿s indicated failure of the stopper separating from the plunger rod.There were zero (0) notifications noted that pertained to the complaint.A root cause cannot be determined.

Event Description

It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had plunger loose issues.The following information was provided by the initial reporter: the consumer reported that when drawing with 1 syringe the stopper came away from plunger rod.Date of event: unknown.Sample status: awaiting sample.

• Brand Name: BD INSULIN SYRINGE WITH 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12906329
• MDR Text Key: 284307116
• Report Number: 1920898-2021-01250
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• 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: 12/13/2021

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: 328411
• Device Lot Number: 1047965
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2021
• Initial Date FDA Received: 12/01/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/16/2021
• 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
• Patient Sex: Female