MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN

Catalog Number 326631

Device Problem Defective Device (2588)

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

Event Date 02/18/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: samples were received and an investigation was performed.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for 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.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: a complaint history check was performed and this is the 1st related complaint for barrel damaged/cracked on lot # 0055935.Customer returned (1) 3/10cc, 12.7mm, 29g syringe in an open poly bag from lot # 0055935.Customer states that a crack was found onto the barrel.The returned syringe was examined and exhibited scratches in the barrel from the 5-10 unit markings.Manufacturing ((b)(4)) will be notified of this issue.A review of the device history record was completed for batch # 0055935 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.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 (scratched barrel) 08mar2021, (b)(4) received a photo complaint from material #326631 and lot #0055935; syringe 0.3ml 29g 1/2in examination of the photo indicates scratch print all around the barrel affecting the print quality.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.Device history record; l2l and logbook evaluation: the device history (dhr) for batch 0055935 was reviewed.The syringes were printed at the printer operation from 09mar2020 to 11apr2020.During the manufacturing process, the following inspections are completed on regular intervals: visual inspection every 30 minutes: one or more scale lines missing.½ of the scale line must be visible.Visual inspection every 30 minutes: density of print; too light, too dark, shadow print; discolored print.Visual inspection every 30 minutes: cosmetic condition such as mis formed/broken scale lines, numbers, or letters.Functional inspection once per shift: scale marking ink permanency test.Root cause: l2l #93886 was dispatched.On 08apr2020 for scratches on the barrel from the oven chain ears.Corrective action: tighten the chains and sprockets.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 0.3ml 29ga 1/2in experienced device damage/deformation while still considered operable.The following information was provided by the initial reporter: according to the customer's report, a crack was found onto the barrel.

• Brand Name: SYRINGE 0.3ML 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: 11499474
• MDR Text Key: 251487540
• Report Number: 1920898-2021-00303
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326631
• Device Lot Number: 0055935
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2020
• 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