MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ II LANCET

Catalog Number 326572

Device Problem Unsealed Device Packaging (1444)

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

Event Date 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Device manufacture date: unknown.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 the bd ultra-fine¿ ii lancet packages were open and the seal was broken.Found before use.No serious injury or medical intervention noted.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check could not be performed for the defect/condition reported since the lot number was not provided.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.Dhr could not be performed as the lot number was not provided.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.

• Brand Name: BD ULTRA-FINE¿ II LANCET
• Type of Device: LANCET
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 7314681
• MDR Text Key: 101721501
• Report Number: 9616656-2018-00039
• Device Sequence Number: 1
• Product Code: FMK
• Combination Product (y/n): N
• PMA/PMN Number: K932725
• 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: 04/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 326572
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 02/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other