MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2020-03-11 for IV3000 1 HAND 10X12CM CTN 50 4008 manufactured by Smith & Nephew Medical Ltd..
[183086083]
Investigation results: we have now concluded our investigation for the complaint received. A review of the associated batch manufacturing records did not identify any issue at the point of manufacture which may have caused or contributed to the issue highlighted by the complainant. In addition it can be confirmed that all finished product specification testing was satisfied at the point of release. A complaints history review was carried out using the lot and part numbers provided, there have been no further complaints reported with this issue in the past three years. The devices were intended to be used for treatment, however, it reported that defects were identified on the film of the dressing. The returned samples were assessed. A visual and functional evaluation identified delamination of the film on all returned samples. This confirmed a relationship between the reported event and the device. Delamination is a low level intermittent fault which if seen is tabbed for removal during the conversion process. During the manufacturing of the dressing, in process checks are undertaken for this product. All material is manufactured according to the specification and only product meeting the release criteria will be passed on for further processing. The root cause was identified as manufacturing process error. Improvements were made to the machine that manufactures this product which has reduced the occurrence of delamination on this product. Therefore no further actions 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.
Patient Sequence No: 1, Text Type: N, H10
[183086084]
It was reported that when iv3000 was used, it was found that there were defects in the film. A backup device was available. It was found during the investigation that the problem presented by the product was delamination.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8043484-2020-00143 |
| MDR Report Key | 9821717 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-11 |
| Date of Report | 2020-03-11 |
| Date of Event | 2020-01-06 |
| Date Mfgr Received | 2020-03-02 |
| Date Added to Maude | 2020-03-11 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DR SARAH FREESTONE |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal | HU3 2BN |
| Manufacturer Phone | 4407940038 |
| Manufacturer G1 | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Street | 101 HESSLE ROAD |
| Manufacturer City | HULL HU3 2BN |
| Manufacturer Country | UK |
| Manufacturer Postal Code | HU3 2BN |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | IV3000 1 HAND 10X12CM CTN 50 |
| Generic Name | TAPE AND BANDAGE, ADHESIVE |
| Product Code | KGX |
| Date Received | 2020-03-11 |
| Catalog Number | 4008 |
| Lot Number | 1905 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW MEDICAL LTD. |
| Manufacturer Address | 101 HESSLE ROAD HULL HU3 2BN UK HU3 2BN |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-11 |