MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problems Failure to Deliver (2338); Defective Device (2588)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that 1/2 ml bd safetyglide¿ insulin syringe with attached needle barrel was broken.This was discovered during use.The following information was provided by the initial reporter: broken barrel.Nursing staff couldn't draw medicine while taking the medicine and found the needle base was broken.

Event Description

It was reported that 1/2 ml bd safetyglide¿ insulin syringe with attached needle barrel was broken.This was discovered during use.The following information was provided by the initial reporter: broken barrel nursing staff couldn't draw medicine while taking the medicine and found the needle base was broken.

Manufacturer Narrative

Investigation summary: customer returned (1) 1/2ml, 8mm, 30g bd safetyglide insulin syringe in an open blister pack from lot # 8325559.Customer states that they couldn't draw medicine while taking the medicine and found the needle base was broken.The returned syringe was examined and exhibited a piece of the barrel broken off ranging from the 0-14 unit marking, which could make it difficult for the syringe to draw properly.A review of the device history record was completed for batch# 8325559.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200789164] 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.As per investigation completed by manufacturing, "on (b)(6)2019, holdrege received a photo of (1) 0.5ml 30ga tw 8mm bd safety glide insulin syringe from material 305934, batch 8266742.A review of the photo found a syringe with a broken barrel from the zero line to the 20-scale unit marking.The safety mechanism is still intact to the barrel.The barrel is not bowed nor does the barrel and/or plunger display any damage.From this visual inspection the damage may have occurred at the printer operation.Process: 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.Root cause: none/cannot be determined investigation: ¿ a visual inspection is performed every half hour for print and barrel component defects.¿ no documented failures (cracked barrels) at the inspection dial.¿ no documented failures (cracked barrels) at the inhabit gate.¿ no documented failures (cracked barrels) at the infeed dial transition.¿ no documented failures (cracked barrels) at the transfer dial to oven or dial oven.¿ there are no l2l dispatches, logbook entries or notifications for missing components from the time that this batch was produced capa 1187550 was opened to address this issue.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.".

• Brand Name: 1/2 ML BD SAFETYGLIDE INSULIN SYRINGE WITH ATTACHED NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9451209
• MDR Text Key: 182747168
• Report Number: 1920898-2019-01409
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K992734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 305934
• Device Lot Number: 8325559
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other