MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH NEEDLE

Catalog Number 305930

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 the rubber stopper of a 1 ml bd safetyglide¿ insulin syringe with needle separated from the plunger.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that the rubber stopper of a 1 ml bd safetyglide¿ insulin syringe with needle separated from the plunger.There was no report of exposure, injury or medical intervention.

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: device returned to manufacturer: yes.

Event Description

It was reported that the rubber stopper of a 1 ml bd safetyglide¿ insulin syringe with needle separated from the plunger.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

H.6.Investigation summary: two investigations were carried out.First investigation summary: customer returned (1) loose 1cc safetyglide insulin syringe.Customer states that when pulled the plunger, the rubber stopper was separated from plunger.The returned syringe was examined and when trying to draw the plunger back, the stopper separated from the plunger.Sample was forwarded to manufacturing (holdrege) on 29jun2018 for further review.Second investigation summary: holdrege received one (1) loose 1ml bd safetyglide syringe from reported batch# 6351514.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.Closer evaluation of the plunger rod noted that there was a molding defect at the plunger tip which could cause the stopper to not completely seat onto the plunger rod during assembly.A correctly molded plunger rod was assembled into the complaint sample and noted the expected functionality of the device.A review of the device history record was completed for batch# 6351516.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200676963] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for stopper separated from plunger on lot # 6351514.Probable root cause likely to be a molding defect which temporarily allowed for the stopper to seat on the plunger rod for assembly into the syringe, however, was insufficient to withstand the break out/sustaining forces for device utilization.Based on the samples / photo(s) received the investigation concluded: - confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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.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: 1 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH NEEDLE
• Type of Device: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7635305
• MDR Text Key: 112328041
• Report Number: 1920898-2018-00441
• 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,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: 305930
• Device Lot Number: 6351514
• Date Manufacturer Received: 06/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other