MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. PICO 7 10CM X 20CM; TAPE AND BANDAGE, ADHESIVE

Catalog Number 66802002

Device Problem Pumping Stopped (1503)

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

Event Date 11/05/2020

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case-2020-00027387-1.

Event Description

It was reported that when batteries were inserted to a brand-new pico 7 and the start button was pushed, the device did not work.It is unknown if the indicator lamps were illuminated.A wound dressing was temporally applied on the wound, and npwt is supposed to be restarted as soon as the hospital receive a backup device.No patient harm.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as no lot number was provided, however, there are no indications to suggest that the device did not meet specifications upon release into distribution.The complaint history file contains further instances/ related events of the reported event.The device was used for treatment.The device was not returned for analysis.The reported issue may be linked to application or procedural technique.A clinical investigation concluded: ¿per the complaint details, the brand-new pico device failure occurred during setup prior to use on the patient.Based on the information provided, a temporary dressing was applied to the patient¿s wound until the hospital receives a backup device.Per subsequent email the device was discarded by the hospital.Since there was no harm to the patient, no further clinical/medical assessment is warranted at this time.Should additional medical information be provided, this complaint will be re-assessed.¿ the instructions for use provides comprehensive instructions of the operation, use and limitations of the device.The associated risk file contains the reported event.We have not been able to confirm a relationship between the event and the device or identify a definitive root cause.No further actions by smith and nephew are deemed necessary at this stage.However, we will continue to monitor for any adverse trends relating to this product range.Smith and nephew acknowledge customer concern and are continually investigating ways to develop and improve our products.(b)(4).

• Brand Name: PICO 7 10CM X 20CM
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull east riding of yorkshire HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10938781
• MDR Text Key: 219294118
• Report Number: 8043484-2020-04035
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 66802002
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention