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

Catalog Number 328290

Device Problem Complete Blockage (1094)

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

Event Date 12/17/2021

Event Type  malfunction  

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.

Event Description

It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had aspiration and injection issues.The following information was provided by the initial reporter : the consumer reported 1 syringe that will not draw up insulin.Date of event : unknown.Samples status : available.

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 review of the device history record was completed for batch# 9035759.All inspections and challenges were performed per the applicable operations qc specification.There were two (2) notifications noted that did not pertain to the complaint.H3 other text : see h10.

Event Description

It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had aspiration and injection issues.The following information was provided by the initial reporter: the consumer reported 1 syringe that will not draw up insulin.Date of event : unknown.Samples status : available.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2022-mar-08.H6: investigation summary: customer returned a single 0.5ml, 31 gauge, 8mm syringe from lot 9035759.Operating the plunger found that it would not hold its position when released, instead being drawn back to the tip of the syringe barrel.When attempted, the syringe was unable to draw water.A rod was inserted into the needle¿s cannula.An obstruction was found shortly down the length of the cannula.The obstruction could not be dislodged using force.A review of the device history record was completed for batch# 9035759.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.Based on the sample received, bd was able to confirm the customer¿s indicated failure of a needle clog.Based on the sample received, bd was able to confirm the customer¿s indicated failure of the syringe not drawing fluid.Root cause for this defect cannot be determined.H3 other text : see h10.

Event Description

It was reported that 1 bd insulin syringe with bd ultra-fine¿ needle had aspiration and injection issues.The following information was provided by the initial reporter: the consumer reported 1 syringe that will not draw up insulin.Date of event : unknown.Samples status : available.

• Brand Name: BD INSULIN SYRINGES 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 13239825
• MDR Text Key: 285240746
• Report Number: 1920898-2021-01395
• 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,Followup
• Report Date: 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 328290
• Device Lot Number: 9035759
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2019
• 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