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

Catalog Number 329459

Device Problems Break (1069); Retraction Problem (1536)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/12/2018

Event Type  Injury  

Manufacturer Narrative

(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 with the use of the bd¿ insulin syringe there was an issue with needle stick injury.When safety mechanism was activated it broke causing a dirty needle stick injury.The device user was directed to a doctor for exposure screening.No additional treatment was required.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 8010798.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200730000] noted for spinnners severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 8010798.Based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.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.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported with the use of the bd¿ insulin syringe there was an issue with needle stick injury.When safety mechanism was activated it broke causing a dirty needle stick injury.The device user was directed to a doctor for exposure screening.No additional treatment was required.

• Brand Name: BD¿ INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7939268
• MDR Text Key: 123043191
• Report Number: 1920898-2018-00766
• 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,other
• Type of Report: Initial,Followup
• Report Date: 10/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 329459
• Device Lot Number: 8010798
• Date Manufacturer Received: 09/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention