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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE

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BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA 8MM PISTON SYRINGE Back to Search Results
Catalog Number 320440
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/24/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used for this field. Investigation summary : exec summary - samples were received and an investigation was performed. A complaint lot history check was performed and this is the 1st. Related complaint for printing scale marking missing on 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. Samples returned - customer returned five 0. 3ml syringes with no other identification. Three of the five syringes feature missing surface and scale markings. Two of these syringes are entirely blank while the third is missing the majority of these markings. Manufacturing ((b)(4)) will be notified of this issue. Photos - 07sep2021, (b)(4) received a photo complaint from material #320440 and lot #1004344; syringe 0. 3ml 31g 8mm: initial evaluation: examination of the photo indicates no print on the barrel. Manufacturing evaluation: a review of the printer line where the syringe in question was produced was completed. Process summary: blank barrels are transferred from totes to a bulk hopper, the hopper then meters them into the vibratory feeder which orients and transfers the barrels single file into the first inline feeder. The first inline feeder rail transfers to the inspection dial where short molding defects are rejected. After the inspection dial the barrels are transferred to the second inline feeder and transitions through the corona treater terminating at the inhibit gate. At cycle start the inhibit gate opens, introducing barrels to printer infeed dial on through the flange guide which aligns the flanges for proper registration and into the print carousel where ink images are applied. From the print carousel the barrels are transitioned to the transfer dial and into the curing oven. The cured product exits the oven chute for transfer to the next operation. Maintenance dispatch (l2l) was reviewed and dispatch was generated for print concerns. Root cause: the ink pump completely stopped pumping ink. No print was being applied to the barrel. Corrective action: operation stopped immediately and replaced the fuses in the ink pump. Capa/sa - based on the above investigation no additional investigation and no corrective or preventative action (capa) or situational analysis (sa) are required at this time. Dhr review - a lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.
 
Event Description
It was reported that 5 bd syringe 0. 3ml 31ga 8mm had scale marking issues. The following information was provided by the initial reporter : it was reported by the bd employee that there were markings missing on the side of the returned sample syringes.
 
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Brand NameBD SYRINGE 0.3ML 31GA 8MM
Type of DevicePISTON 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 Key12511164
MDR Text Key272655356
Report Number1920898-2021-01010
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K024112
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number320440
Device Lot Number1004344
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/24/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/04/2021
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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