MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN

Catalog Number 326666

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 06/28/2021

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.Device manufacture date: unknown.Investigation summary: samples were received and an investigation was performed.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 situation analysis (sa) is required at this time.Investigation conclusion: unable to perform complaint lot history check for needle bent due to unknown lot number.Manufacturing ((b)(4)) will be notified of the observed issue.Due to the batch being unknown, no dhr review can be completed.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 (cannula bent, cannula shield damaged) 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)(6) received a photo complaint of a 0.5ml syringe with an unknown batch for needle bent with shield damage a visual evaluation of the picture was done and a bent cannula was seen with shield damage on the bottom of the shield.Process summary: the hub loader machine feeds the hub from a random orientation and places them onto a transportation rack for further processing.Then the cannulator machine corona treat hubs, transfer cannula into hubs and applies adhesive.Next is the oven which provides a uv energy to cure the adhesive in order to achieve necessary cannula removal forces.After that the lube machine applies silicone lubrication to the cannula.The next step is the vision inspection machine, which performs the function of inspecting points, cannula length, cannula angularity, correct adhesive amount and the cannula bore.Good parts are shielded at the shielder machine and then picked from the racks and placed in the final material conveying system for the next operation.Defects are tracked and stripped from fixturing rack.Rack is then empty and ready to be reloaded with hubs.Due to the batch being unknown, no dhr review was able to be completed and machine dispatches could not be reviewed.A root cause cannot be determined.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 the syringe 0.5ml 29ga 1/2in experienced molding defect -sharp protrusions.The following information was provided by the initial reporter: according to the customer's report, when removing the shield, the hcp found that the needle was bent from the root.

• Brand Name: SYRINGE 0.5ML 29GA 1/2IN
• Type of Device: 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: 12238600
• MDR Text Key: 263873307
• Report Number: 1920898-2021-00824
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326666
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• 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