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

Catalog Number 328438

Device Problems Complete Blockage (1094); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/26/2022

Event Type  malfunction  

Manufacturer Narrative

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 the bd ultra fine¿needle had foreign matter in the fluid path and was unable to inject insulin.The following information was provided by the initial reporter : the customer reported that it looks like there is silicon in just the one syringe and it can not go through the needle.Date of event : (b)(6) 2022.

Event Description

It was reported that 1 bd insulin syringe with the bd ultra fine¿needle had foreign matter in the fluid path and was unable to inject insulin.The following information was provided by the initial reporter : the customer reported that it looks like there is silicon in just the one syringe and it can not go through the needle.Date of event : (b)(6) 2022.

Manufacturer Narrative

H.6.Investigation: customer returned (1) loose 3/10cc, 8mm syringe.Customer states that there is silicon in the syringe and it cannot go through the needle.The returned syringe was examined and exhibited a hard piece of plastic in the barrel, which could prevent the insulin from properly functioning.A review of the device history record was completed for batch # 0114506 all inspections were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause: maintenance dispatch (l2l) was created for a broken air hose at the prep dial inhabit gate.At the barrel cleaning dial, the printed barrel is received to the barrel prep dial where air passes from probes and blows out any fm that may be within the barrel id downward and out through the tip.The air hose was not functioning.There is not root cause identified why the hose was broke.

• 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: 13499412
• MDR Text Key: 285497590
• Report Number: 1920898-2022-00086
• 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: 02/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: 0114506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2020
• 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