MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SAFETYGLIDE¿ 6MM INSULIN SYRINGE

Catalog Number 928856

Device Problem Bent (1059)

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

Event Date 10/26/2017

Event Type  malfunction  

Manufacturer Narrative

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 that a walgreen¿s consumer stated when he/she inserted a bd safetyglide¿ 6mm insulin syringe into a vial and it would not draw up the medication.The barrel and plunger appeared to be bent.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one syringe in an open poly bag from lot # 7058717 without the shield.Customer states that the barrel is bent, it would not draw, and the plunger is bent.The returned syringe was examined and exhibited a bent/dented barrel and a bent/dented plunger rod.This would cause the plunger to be difficult to move through the barrel.Sample will be forwarded to manufacturing ((b)(4)) on 15dec2017 for further review.Conclusion: an absolute root cause for this incident cannot be determined.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.

Manufacturer Narrative

Results - holdrege received one (1) 1ml, 8mm, 31g syringe without shield in opened polybag from batch# 7058717.All samples were decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, it was noted that the received sample was without shield, resulting in a hooked cannula tip.The barrel of the sample exhibited a bowed appearance with stress fractures within the barrel wall, extending through the plunger rod as well.This type of damage is indicative of a likely jaw jam on the form fill & seal (ff&s).In such instances, any part or component of a syringe may be caught in the jam, resulting in damage to the component that generally renders the device inoperable by the end user.The damaged syringe and/or component(s) are typically found in the sealed polybag at a later time.Conclusion - as the sample was received without a shield upon initial investigation in franklin lakes, probable root cause is unable to be determined or identified to be a manufacturing related issue.

• Brand Name: BD SAFETYGLIDE¿ 6MM INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7060382
• MDR Text Key: 93494309
• Report Number: 1920898-2017-00332
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2022
• Device Catalogue Number: 928856
• Device Lot Number: 7058717
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other