MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. IV3000 1 HAND 10X12CM CTN 50; TAPE AND BANDAGE, ADHESIVE

Catalog Number 4008

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Skin Irritation (2076); Injury (2348)

Event Date 09/07/2020

Event Type  Injury  

Event Description

It was reported that the patient was transferred from endocrinology to thyroid and breast surgery on (b)(6) 2020 due to lymph node metastasis of breast cancer.After discussion, it was decided to give the patient implantation in the linear infusion port under local anesthesia.On (b)(6) 2020, the patient complained itch.The skin under the dressing was found red and there were scattered small blisters around the dressing.The dressing was replaced immediately and disinfected with alcohol and iodophor, and external applied with recombinant bovine basic fibroblast growth factor gel.After that the patient said that there was no pruritus on the skin, the skin redness and swelling were alleviated, most of the small blisters had been absorbed, and no other adverse consequences occurred.

Manufacturer Narrative

We have now concluded our investigation for the complaint received.A review of the batch manufacturing records could not be performed as the lot number provided is not a valid lot number for this product, however, there are no indications to suggest that the device did not meet specifications upon release to distribution.A complaint history review was carried out using the part number provided, there have been further complaints reported with this failure mode in the past three years.A risk management review was carried out.The risk files for this product contain multiple causes of type 4 sensitization reactions and irritant / irritation contact dermatitis such as dressing passed expiry date, incorrect storage of dressing and patient allergy to dressing components.Without further information into the causes of the harm, a precise failure mode cannot be assigned.The device was used for treatment.As no samples were returned a product evaluation could not be carried out.A clinical investigation was carried out.It was concluded: ¿the information provided is insufficient to determine whether the patient¿s symptoms are due to a pre-existing or concurrent medical condition (allergy history, skin/dermal sensitivities).Furthermore, it was reported the iv3000 was removed immediately.Per communications, the area was disinfected with alcohol and iodophor, in addition to, an external application of recombinant bovine basic fibroblast growth factor gel.Afterwards, the patient stated, ¿there was no pruritus on the skin, the skin redness and swelling were alleviated, and most of the small blisters had been absorbed.¿ since there were no other adverse consequences reported, no further clinical/medical, assessment warranted at this time.¿ as with all adhesive products some irritation can occur during application and removal, particularly on patients with sensitive skin.We have not been able to confirm a relationship between the event and the device or identify a 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.

• Brand Name: IV3000 1 HAND 10X12CM CTN 50
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hull HU3 2 BN; UK HU3 2BN
• MDR Report Key: 10693835
• MDR Text Key: 211835926
• Report Number: 8043484-2020-03230
• Device Sequence Number: 1
• Product Code: KGX
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• 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: 11/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 4008
• Device Lot Number: 18479658
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/16/2020
• Supplement Dates Manufacturer Received: 11/13/2020
• Supplement Dates FDA Received: 11/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR