MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE; SAFETY SYRINGE WITH NEEDLE

Catalog Number 305950

Device Problem Unintended Ejection (1234)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that when attempting to activate the safety feature on a bd safetyglide¿ syringe allergist tray with needle, the ¿entire needle fixture flew off of the syringe and flew across the room¿.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Investigation summary: two investigations were carried out.First investigation summary: customer returned (1) 1ml, 13mm, 27g bd safetyglide allergy syringe with the tray cover from lot # 7072717.Customer states that after injection when attempting to activate the safety mechanism, the entire needle fixture flew off of the syringe and flew across the room.The syringe was returned with the hub-needle-safety mechanism assembly separated from the barrel.No damage to the barrel was observed.Sample will be forwarded to manufacturing (b)(4) on 11may2018 for further review.Second investigation summary: on 22may2018, (b)(4( received one (1) 1ml, 13mm, 27g bd safetyglide allergy syringe with tyvek tray cover from batch# 7072717.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.Damage to the hub core and barrel tip were noted, consistent with a misalignment during production, specifically with the assembly of the hub to the barrel.When this occurs, an incomplete seating of the hub within the barrel tip can occur and lead to the hub detaching from the remainder of the device, with the cannula/safety mechanism, either during transport or initial activation of the product.A review of the device history record was completed for batch # 7072717.All inspections were performed per the applicable operations qc specifications.Syringe assembly ¿ there were five (5) batches of material# 8365025(syringe 1.0ml asm 27ga 1/2in sg sm700169) that went into the finished batch# 7072717: batch # 7051583 was manufactured from 09apr2017 to 20apr2017.Batch # 7051582 was manufactured from 09apr2017 to 17apr2017.Batch # 7040804 was manufactured from 30mar2017 to 07apr2017.Batch # 7040803 was manufactured from 29mar2017 to 07apr2017.Batch # 7040800 was manufactured from 10mar2017 to 17mar2017.There were zero (0) notifications noted that pertained to the complaint.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint reported with the defect/condition of safety mechanism broke (safetyglide) with lot #7072717 regarding item #305950.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.

• Brand Name: BD SAFETYGLIDE¿ SYRINGE ALLERGIST TRAY WITH NEEDLE
• Type of Device: SAFETY SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7526774
• MDR Text Key: 109236006
• Report Number: 1920898-2018-00317
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903059509
• UDI-Public: 30382903059509
• 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
• Report Date: 06/12/2018

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 Expiration Date: 02/28/2022
• Device Catalogue Number: 305950
• Device Lot Number: 7072717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Initial Date Manufacturer Received: 04/25/2018
• Initial Date FDA Received: 05/18/2018
• Supplement Dates Manufacturer Received: 04/25/2018
• Supplement Dates FDA Received: 06/12/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other