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

Catalog Number 324910

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).Investigation summary: samples were received and an investigation was performed.This is the 1st complaint for the reported lot number.A review of the manufacturing records was performed and one non-conformance was raised in association with this type of event for this lot.Bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint for stopper damaged on lot # 0167709.Investigation summary: customer returned (100) 3/10cc, 6mm, 31g syringes (10 in an open poly bag, 90 in sealed poly bags) with the shelf carton from lot # 0167709.Customer states that the rubber stopper is distorted so unable to measure insulin.Thirty out of 100 returned syringes (all 10 from the open poly bag, 20 from the sealed poly bags) were examined and 8 out of 10 samples from the open poly bag and 18 out of 20 samples from the sealed poly bags exhibited a deformed stopper.Manufacturing ((b)(4)) will be notified of this issue.A review of the device history record was completed for batch # 0167709 all inspections were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] noted that did not pertain to the complaint.There was one (1) notification [(b)(4)] noted for insufficient barrel lube.Based on the samples and/or photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.On (b)(6) 2021, (b)(4) received a complaint, via a picture, from material 324910, batch 0167709.Visual inspection of the picture showed stoppers leading edge was angled and not straight across.Process summary: the automatic syringe assembly machine feeds 0.3ml syringe components (barrel, stopper, plunger, and cap) and assembles these components.This machine consists of a barrel-cleaning dial, lubrication dial, one plunger/stopper assembly dial and one syringe assembly dial and various inspection and transfer dials.A dry barrel could result in the lack of silicone in the barrel allowing the plunger / stopper to move with limited ease.Notification (b)(4) was created for smeared stoppers due to no silicone during the production of this batch.The root cause was found to be a loose fitting and damaged lines.The issue was corrected by tightening and replacing the parts.The affected product was segregated and destroyed.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that 200 bd insulin syringes with bd ultra-fine¿ needles experienced stopper deformation.The following information was provided by the initial reporter: rubber stopper is distorted so unable to measure insulin.

• 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: 11373403
• MDR Text Key: 233319045
• Report Number: 1920898-2021-00218
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 324910
• Device Lot Number: 0167709
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2020
• 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