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

Catalog Number 326675

Device Problem Missing Information (4053)

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

Event Date 11/08/2022

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 9 bd ultra-fine¿ insulin syringes were missing the lot number on their labeling.The following information was provided by the initial reporter: "missing lot number.".

Manufacturer Narrative

Investigation summary: a complaint lot history check was performed on lot # 1067894 for package printing defect.This is the 2nd related complaint for package printing defect on lot # 1067894.Relate complaints - (b)(4) a review of risk management 150rmn-0001-16 revision 15 indicates that the potential risk of this specific reported incident (syringe, package printing defect) was captured and addressed.Investigation summary: no samples were returned therefore the investigation was performed based on the photos provided.The customer returned several images of the 31gx6mm bd insulin syringe shelf carton from lot# 1067894.The customer reported missing lot information and incorrect position as well as torn box.The photos were examined, and although none of the photos shows a torn box, the photos does reveal that the printed lot number, manufacturing date, and expiration date were missing from the back of the shelf carton and printed on the front side of the shelf carton as opposed to the back, resulting in this information overlapping with the material number instead of its intended location.A review of the device history record was completed for batch# 1067894.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200960911] noted that did not pertain to the complaint.Based on the images received, embecta was able to confirm the customer¿s indicated failure of a printing defect.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.Manufacturing (holdrege) will be notified of this issue.Complaint #(b)(4) catalog #: 326725 batch #: 1067894 catalog description: syringe 0.5ml x 31g x 6mm b/p ap issue: package printing defect & shelf carton damage analysis of sample: 1.Visual inspection of the photo displays a carton with coding in the required location of the carton, however the leading line of the coding (the batch number) is printed on top of the material number that is preprinted on the carton.2.Visual inspection of the photo displays a shelf carton that has a slight tear on the top corner.The tear does not affect any of the labeling nor is large enough to allow a packaged syringe to fall through.Process: the blister pack machine packages the syringes into a sequence of individually formed pockets in the bottom web that is heat-sealed with the top web and then cut into individual blisters.Sealed blisters are then conveyed and picked and placed into a shelf carton.The full cartons are conveyed across a scale to ensure that the correct number of syringes have been placed in the carton.If an incorrect quantity is detected or the carton is not closed correctly, the full carton automatically conveys to a rework station.Upon completion of the rework, the full carton is manually introduced by the associate back into production prior to the scale investigation: if a defect is found during an inspection a quality notification is initiated.No quality notifications were written for issues relating to the packaging defect.L2l dispatches were all reviewed, and there were no maintenance dispatches that pertained to this defect during the production of this batch.Eos (end of shift) reports were reviewed, a notation was made for carton and casepack jams occurring due to the carton lids ¿curling/bending¿.This is occasionally seen from the vendor when the cartons are removed from the bulk packaging prior to being used for the packaging process.The vendor is notified when this occurs.The operator was directed to pre-bends the cartons prior to loading them into the carton erector machine.¿prebending¿ the cartons aides in cartons forming correctly prior to loading the carton with packaged syringes.However, occasionally the carton lid may come open after the syringes have been added or when conveying to the case pack.Root cause & correction: in the event the carton comes open when conveyed into the case pack and any slight damage is noted to the carton, the syringes are removed and repacked into a new carton.An inspection of the syringes in the blister is performed to ensure no damage and then repacked into a new erected carton.The new carton with syringes is to be placed onto the transfer belt prior to the scale and coding station.No coding on the carton signifies the full carton was manually introduced after the scale / coding process.Quality: 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 9 bd ultra-fine¿ insulin syringes were missing the lot number on their labeling.The following information was provided by the initial reporter: "missing lot number.".

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• 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: 15913105
• MDR Text Key: 305908280
• Report Number: 1920898-2022-00840
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382906675019
• UDI-Public: (01)00382906675019
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/09/2022

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: Other
• Device Catalogue Number: 326675
• Device Lot Number: 1067894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/08/2022
• Initial Date FDA Received: 12/05/2022
• Supplement Dates Manufacturer Received: 12/09/2022
• Supplement Dates FDA Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/08/2021
• 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