MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. NO STING SKIN PREP SPRAY JAPAN

Catalog Number 66800872

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/21/2021

Event Type  Injury  

Event Description

It was reported that the spray pump of the no sting skin prep spray (b)(6) did not work appropriately.When the spray pump was pushed, the liquid was dripping and leaked.The patient was treated with a different technique without delays.The patient was not harmed.

Manufacturer Narrative

The device, intended for use in treatment, was returned for evaluation.A visual inspection reported when the spray pump was pushed, the liquid was dripping and leaked, establishing a relationship with the reported event.The root cause was identified as a component failure.The instructions for use provide comprehensive instructions of the operation, use and limitations of the device.The associated risk files contain details relating to harm.However, as no harm has been alleged then additional review is not required.The manufacturing records show no evidence that the product did not meet specification at the time of manufacture.Complaint history review found further instances of the reported events.This investigation is now complete with no further action deemed necessary at this stage.Smith + nephew are taking further actions relating to the failure reported and continue to monitor for adverse trends.

• Brand Name: NO STING SKIN PREP SPRAY JAPAN
• Type of Device: NO STING SKIN PREP SPRAY JAPAN
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 11921059
• MDR Text Key: 253965976
• Report Number: 8043484-2021-01340
• Device Sequence Number: 1
• Product Code: NEC
• UDI-Device Identifier: 04582111180322
• UDI-Public: 4582111180322
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66800872
• Device Lot Number: 61807
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention