MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number 305930

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/25/2018

Event Type  Injury  

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 the nurse got a needle stick after use with a bd safetyglide¿ insulin syringe with bd¿ needle.No medical intervention was reported.

Event Description

It was reported that the nurse got a needle stick after use with a bd safetyglide¿ insulin syringe with bd¿ needle.No medical intervention was reported.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8002680.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle stick after use on lot # 8002680.Based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other, device single use?: no, device returned to manufacture: no.

Event Description

It was reported that the nurse got a needle stick after use with a bd safetyglide¿ insulin syringe with bd¿ needle.No medical intervention was reported.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE WITH BD¿ NEEDLE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7781253
• MDR Text Key: 117128614
• Report Number: 1920898-2018-00622
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2023
• Device Catalogue Number: 305930
• Device Lot Number: 8002680
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other