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

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.

• Brand Name: BD SYRINGE 0.3ML 31GA 8MM
• 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: 12511164
• MDR Text Key: 272655356
• Report Number: 1920898-2021-01010
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320440
• Device Lot Number: 1004344
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2021
• 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