MAUDE Adverse Event Report: SMITH & NEPHEW MEDICAL LTD. OPSITE; TAPE AND BANDAGE, ADHESIVE

Catalog Number UNKNOWN

Device Problem Migration (4003)

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

Event Date 01/01/1901

Event Type  malfunction  

Event Description

It was reported that the aim of this prospective and randomised study was to determine whether the tunnelling of an epidural catheter influences its migration.Patients were randomly allocated to receive one of two methods of skin fixation according to a previously prepared protocol.The method of epidural catheter insertion was standardised, and after establishing intravenous access, the patient was placed in the left lateral position.Under aseptic conditions a 16-gauge tuohy needle (portex epidural system 1 minipack) was inserted via a midline approach.The epidural space was located using the loss of resistance to air technique, and with the needle orifice directed cephalad the catheter was inserted 4 cm into the epidural space.The catheter had three side holes at 0.5, 1.0 and 1.5 cm from the distal end and had marks at every 1 cm from 5 to 15 cm and at 20 cm from the tip.The skin and catheter near the skin exit site were sprayed with nobecutan transparent adhesive spray (astra pharmaceuticals pty ltd) and covered with a transparent 10 cm by 12 cm opsite adhesive plastic dressing (smith & nephew medical ltd).Overall 11 catheters migrated inwards by 1 cm or more and 29 migrated 1 cm or more out of the skin, causing 4 dislodged catheters, 1 in the tunnelled group and 3 in the non-tunnelled group.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

The device used in treatment was not returned for evaluation with no additional information provided we have not been able to establish a relationship between the reported event or determine a root cause.Probable root causes include application techniques and or a failed component.The ifu offers further guidance.Medical review concluded, without clinically relevant patient-specific supporting documentation, a thorough medical investigation cannot be performed.The root cause and/or patient outcome beyond that which was documented in the article cannot be confirmed nor concluded; therefore, no further medical assessment is warranted at this time.The associated risk files contain details relating to harm.However, the clinical review has not established a causal link.Additional risk management review is not required.No batch/lot number has been provided, however at this time we have no reason to suspect that the product did not meet specifications at the time of manufacture.A complaint history review found other related failures.This investigation is now complete with no further action deemed necessary.Smith + nephew will continue to monitor for any adverse trends relating to this product range.

• Brand Name: OPSITE
• Type of Device: TAPE AND BANDAGE, ADHESIVE
• Manufacturer (Section D): SMITH & NEPHEW MEDICAL LTD.; 101 hessle road; hul ; UK
• MDR Report Key: 10231180
• MDR Text Key: 197599506
• Report Number: 8043484-2020-01600
• 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: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/26/2021
• Patient Sequence Number: 1