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 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: samples were received and an investigation was performed.This is the 1st 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.Investigation conclusion: a complaint history check was performed and this is the 1st related complaint for flange damaged on lot # 0300014.Manufacturing (holdrege) will be notified of the observed issue.A review of the device history record was completed for batch # 0300014 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200919504] noted that did not pertain 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 (flange broken) 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.(b)(6) 2021, holdrege received a photo complaint from material #326631 and lot #0300014; syringe 0.3ml 29ga x 1/2in.Initial evaluation: a photo of a syringe was sent.Examination of the photo indicates one of the two flanges at the open end of the barrel is ¿broken¿ off where the flange interfaces with the barrel.Manufacturing evaluation: a review of the printing 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 transports 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 0300014 was reviewed.The syringes were assembled from 08dec2020 thru 11dec2020.During the manufacturing process, the following inspections are completed on regular intervals: visual inspection every 30 minutes: damaged barrel defects (split, crack, tear, rip, broke into separate parts) that affect sterility barrier or functionality.Visual inspection every 30 minutes: damaged barrel defects (scratched od, scored, notches, cuts, or lines in a surface) that do not affect sterility barrier or functionality.If a defect is found during an inspection a quality notification is initiated.No notifications were created for this defect.Root cause: maintenance dispatch (l2l) was reviewed, and l2l #111954 was created for barrels jamming causing missing parts at the infeed dial.The barrels are put into a bin where they individually transport down a rail prior to being printed at the printer operation.Air jets control the flow of the barrels entering the rail.When more the one barrel enters the rail, a jam may occur.The printer machine is programmed stop until the jam has been cleared.Any affected product is removed and scrapped.Depending on the severity of the jam, the barrel flange could be weakened and potentially break when used.Correction: adjusted the air jets and the psi on the air jets at the barrel infeed dial.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 product damage while still considered operable.The following information was provided by the initial reporter: according to the customer's report, the flange was found to be chipped when opening the package.

• 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: 12140262
• MDR Text Key: 262695545
• Report Number: 1920898-2021-00734
• 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: 06/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 326631
• Device Lot Number: 0300014
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 07/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/26/2020
• 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