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

Catalog Number 328468

Device Problem Complete Blockage (1094)

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

Event Date 09/09/2021

Event Type  malfunction  

Event Description

It was reported that 4 bd insulin syringes with the bd ultra fine¿needles had injection and aspiration issues.The following information was provided by the initial reporter : it was reported that incorrect insulin dosing with b-d syringes (not all from the same lot) have been happening from not putting air into the vial and they have not drawn out insulin from the vial.

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows : 1.Lot # : 0265850: device expiration date : 09/30/2025, device manufacture date : 09/21/2020.2.Lot # : unknown: device expiration date : unknown, device manufacture date : unknown.The customer's address is unknown.(b)(6), usa has been used as a default.Investigation summary : 1.Exec summary - no samples (including photos) were returned therefore bd was not able to duplicate or confirm the customer¿s indicated failure and the root cause is undetermined.A review of the complaint lot history check was performed and this is the 1st related complaint for unable to operate (not drawing) on lot # 0265850.No non-conformances were raised in association with this type of event for this lot concluding all inspections were performed as per the applicable operations and met qc specifications.No review of the complaint lot history check for difficult or unable to operate was performed on the unknown lot # so the occurrence is unknown, the issue is unconfirmed and root cause can not be determined.2.Capa/sa - based on the above no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time.3.Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot # 0265850 concluding all inspections were performed as per the applicable operations and met qc specifications.

• Brand Name: BD INSULIN SYRINGES WITH THE BD ULTRA FINENEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12715282
• MDR Text Key: 281847426
• Report Number: 1920898-2021-01122
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial
• Report Date: 10/07/2021

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: 328468
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/29/2021
• Initial Date FDA Received: 10/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1