MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ INSULIN SYRINGE

Catalog Number 928856

Device Problems Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/16/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: n/a.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

¿ it was reported during use of the bd safetyglide¿ insulin syringe while drawing the insulin from his vile of medication the needle separated from the hub and got stuck inside vile.There was no report of injury or medical intervention.¿.

Manufacturer Narrative

Investigation summary: customer returned (1) 1cc, 8mm, 31g walgreens syringe in an open poly bag from lot # 7191702.Customer states that while drawing the insulin from his vial the needle separated from the hub and got stuck inside the medication vial.The syringe was returned with the cannula detached and taped to an index card.The syringe was examined under the microscope and exhibited adhesive runoff onto the hub with little adhesive inside the hub.The cannula was also examined and exhibited adhesive on the cannula shaft.Capa (b)(4) has been opened to address this issue for 1ml syringes as per manufacturing, a review of the device history record was completed for batch # 7191702.All inspections and challenges were performed per the applicable operations qc specifications.There were six (6) notifications [200702167, 200701983, 200702254,200682883, 200683596, 200705420] noted that did not pertain to the complaint.Sample will be forwarded to manufacturing (holdrege) on (b)(6)2018 for further review.Based on the samples / photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff) 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.Investigation conclusion: probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive runover onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.Capa (b)(4) has been opened to address this issue for 1ml syringes.

• Brand Name: BD SAFETYGLIDE¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7245423
• MDR Text Key: 99221195
• Report Number: 1920898-2018-00030
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/26/2018

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: Lay User/Patient
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 928856
• Device Lot Number: 7191702
• Initial Date Manufacturer Received: 01/16/2018
• Initial Date FDA Received: 02/06/2018
• Supplement Dates Manufacturer Received: 01/16/2018
• Supplement Dates FDA Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other