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

Catalog Number 324906

Device Problems Disconnection (1171); Material Separation (1562); Component Missing (2306)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: n/a.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 a package of bd veo¿ insulin syringes with bd ultra-fine¿ needles had disconnected needle shields, a missing plunger cap, and needle and syringe separation.There was no report of exposure, serious injury, or medical intervention.

Manufacturer Narrative

Investigation summary: investigation summary: customer returned photos of 3/10cc, 6mm, 31g syringes with the poly bag and shelf carton.Customer states that the syringes are without the shield, the plunger cap is missing, syringes are missing, the shields are loose in the bag, and the plastic package printing stating standard contents of 10 syringes, but the related printing on the box top that states box contains 10 packages totaling 90 syringes per box.The photos were examined and this is the correct labeling on the shelf carton and poly bag and no missing shield was observed.However, it appears from the photos that 3 syringes are missing, one sample exhibited a broken barrel tip, one syringe had the shield separated, and one sample had the plunger cap separated.A review of the device history record was completed for batch # 7177939 all inspections were performed per the applicable operations qc specifications.There were three (3) notifications [200706576, 200706667, 200706595] noted that did not pertain to the complaint.There was one (1) notification [200706575] noted for raised hubs.Based on the samples / photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (missing syringe, broken barrel tip, separated shield, separated plunger cap).-unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (labeling issue, missing shield).Possible root causes for the short count include: machine jam at the form, fill and seal machines (packaging operation) timing between inspection dial and count dial is off which does not complete a smooth transfer of components creating damage.Possible root cause for broken barrel tip: can be caused by the tamping of the packages within the carton to allow closure of the carton.Possible root cause for the separated shield and plunger cap is likely during the auto packaging operation that the shield could catch on the outside of the carton and when the product tamp station presses the air out of the bags the shield could be removed exposing the cannula.This would likely proceed through the system undetected unless it was detected during hourly visual inspections for missing components.Manufacturing has not taken additional steps for detection of this defect at this time.

Event Description

It was reported that a package of bd veo¿ insulin syringes with bd ultra-fine¿ needles had disconnected needle shields, a missing plunger cap, and needle and syringe separation.There was no report of exposure, serious injury, or medical intervention.

• Brand Name: BD VEO¿ INSULIN SYRINGES WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: INSULINE SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8038925
• MDR Text Key: 126514737
• Report Number: 1920898-2018-00843
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 10885403421532
• UDI-Public: 10885403421532
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 11/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 324906
• Device Lot Number: 7177939
• Date Manufacturer Received: 10/16/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other