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

Catalog Number 329460

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Fail-Safe Problem (2936)

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

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone #: (b)(6).Initial reporter facility name: (b)(6).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 when activating the safety mechanism on a bd safety-lok¿ insulin syringe, it "dismantled" and the needle separated and fell on the floor.There was no report of exposure, serious injury or medical intervention.

Manufacturer Narrative

Investigation summary: customer returned one 1cc, 13mm, 29g bd safety-lok insulin syringe in an open blister pack from lot # 5077733.Customer states that when activating the safety mechanism of the syringe 1ml, it dismantled, the needle separated and fell off on the floor and the safety mechanism came off.The syringe was returned with the hub-needle/shield assembly separated from the barrel.No damage to the barrel was observed.Also, the safety mechanism separated from the barrel.Capa (b)(4) and sa bddc-16-861 were both completed for safety-lok hub separates and safety mechanism disassembly and their associated root causes.Batch# 5077733 was noted to be manufactured prior to implementation of any corrective/preventive actions associated with this capa.A review of the device history record was completed for batch #5077733.All inspections were performed per the applicable operations qc specifications.There were zero defects or notifications noted for related defects during the production of these batches.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub and safety mechanism separated).Possible root causes: - increase jams from the worn or incorrect swing fingers causing double load on the hub loader putting extra stress on the hubs causing cracking.- raised hub detection is only challenged once a week which limits the ability to detect this defect in a timely manner.

• Brand Name: BD SAFETY-LOK¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7443255
• MDR Text Key: 106038525
• Report Number: 1920898-2018-00232
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 05/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 329460
• Device Lot Number: 5077733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Date Manufacturer Received: 03/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other