MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG; ANTISTICK SYRINGE

Catalog Number 305937

Device Problem Failure to Deliver (2338)

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 has been reported that one bd¿ syringe 0.3ml 31ga tw 8mm bls 400 sg has been found blocked during use.The following has been provided by the initial reporter: needle block.Cannot be taken when the nursing staff is taking medicine.

Event Description

It has been reported that one bd¿ syringe 0.3ml 31ga tw 8mm bls 400 sg has been found blocked during use.The following has been provided by the initial reporter: needle block cannot be taken when the nursing staff is taking medicine.

Manufacturer Narrative

H.6.Investigation summary: customer returned (1) loose 3/10cc bd safetyglide insulin syringe without any packaging.Customer states that the needle is blocked.The returned syringe was tested and was not able to draw properly.The sample was then wired and the wire was not able to pass through the cannula.A review of the device history record was completed for batch# 8266744.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200760241] 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 16 dec 2019, holdrege received a photo complaint for clogged cannula.A visual evaluation of the (1) syringe returned from the customer appeared to have adhesive clog inside the cannula.Process: ¿ the racks carrying the hub with cannula move further down along a rail, a pullout device moves the cannula out a small distance for adhesive to be applied.¿ during the parts pass under the corona treater pins and exposed to an ion rich corona field, which increases surface energy wettability to aid in the adhesion of the adhesive to the hub.¿ the cannula is then re-inserted into the hub with vacuum.¿ the pim inspection systems looks for adhesive clogs and rejects the needle assemblies in the process.Root cause: adhesive nozzle out of adjustment.Correction: l2l dispatch #25802 was created during the creation of this batch to replace nozzle and adjust the nozzle.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." h3 other text : see section h.10.

• Brand Name: BD SYRINGE 0.3ML 31GA TW 8MM BLS 400 SG
• Type of Device: ANTISTICK SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9452076
• MDR Text Key: 182749450
• Report Number: 1920898-2019-01413
• 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: 01/02/2020

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: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 305937
• Device Lot Number: 8266744
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other