MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG; SYRINGE, ANTISTICK

Catalog Number 305934

Device Problem Failure to Deliver (2338)

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

Event Date 02/18/2019

Event Type  malfunction  

Manufacturer Narrative

Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the syringe 0.5ml 30ga tw 8mm bls 400 sg experienced an inability to inject insulin during use.The following information was provided by the customer: verbatim: ¿unable to pump drugs".See pr for additional details.Complaint summary detail: this complaint is mdr reportable.The intended use of the device is to deliver insulin which did not occur.This event could lead to hyperglycemia, serious injury or harm.Event type: unable to inject insulin (clogged/blocked) / malfunction.

Event Description

It was reported that the syringe 0.5ml 30ga tw 8mm bls 400 sg experienced an inability to inject insulin during use.The following information was provided by the customer: verbatim: ¿unable to pump drugs".See pr for additional details.Complaint summary detail: this complaint is mdr reportable.The intended use of the device is to deliver insulin which did not occur.This event could lead to hyperglycemia, serious injury or harm.Event type: unable to inject insulin (clogged/blocked) / malfunction.

Manufacturer Narrative

Investigation summary: customer returned (1) loose bd 1/2cc safetyglide insulin syringe without any packaging.Customer states that they are unable to pump drugs.The returned syringe was tested and was able to draw and expel properly without any observed defects.Unable to perform complaint lot history check due to unknown lot number.Based on the samples and/or photo(s) received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.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.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: SYRINGE 0.5ML 30GA TW 8MM BLS 400 SG
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8412893
• MDR Text Key: 139070496
• Report Number: 1920898-2019-00251
• 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: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305934
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 02/25/2019
• Initial Date FDA Received: 03/12/2019
• Supplement Dates Manufacturer Received: 02/25/2019
• Supplement Dates FDA Received: 03/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other