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U.S. Department of Health and Human Services

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

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BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 29GA 1/2IN Back to Search Results
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.
 
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Brand NameSYRINGE 0.5ML 29GA 1/2IN
Type of DeviceSYRINGE
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 Key12238600
MDR Text Key263873307
Report Number1920898-2021-00824
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
NA
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received07/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number326666
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/01/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/09/2021
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

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