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 2018-09-06 for 3M? TEGADERM? I.V. ADVANCED SECUREMENT DRESSING N/A 1680 manufactured by 3m Health Care.
[119339295]
Date of event was not specified. Complaint was created on (b)(6) 2018 was used as date of the event. Incorrect application technique may have contributed to this adverse event report. A cotton ball appeared to be placed under the adhesive of the 1680 tegaderm? Iv advanced securement dressing which would inhibit the dressing from adhering to the catheter and skin for securement. This report was submitted to the fda because the infant required a reinsertion of a picc catheter. End of report.
Patient Sequence No: 1, Text Type: N, H10
[119339296]
A hospital in (b)(6) reported a 1680 tegaderm? Iv advanced securement dressing was applied to a infant's picc catheter site. The infant was reportedly "sweaty, had agitated legs and was in an incubator. " the infant reportedly experienced a 5-10 cm "traction" (dislodgement) of the picc catheter. The infant required a new picc catheter insertion. The dressing reportedly remained intact. No additional information was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2110898-2018-00085 |
| MDR Report Key | 7850227 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2018-09-06 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-07-26 |
| Date Mfgr Received | 2018-08-22 |
| Device Manufacturer Date | 2017-07-01 |
| Date Added to Maude | 2018-09-06 |
| 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 | DIANNE GIBBS |
| Manufacturer Street | 275 5W-06 2510 CONWAY AVE |
| Manufacturer City | ST. PAUL MN 55144 |
| Manufacturer Country | US |
| Manufacturer Postal | 55144 |
| Manufacturer Phone | 6517379117 |
| Manufacturer G1 | 3M COMPANY BROOKINGS |
| Manufacturer Street | 601 22ND AVE SOUTH |
| Manufacturer City | BROOKINGS SD 57006 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 57006 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 3M? TEGADERM? I.V. ADVANCED SECUREMENT DRESSING |
| Generic Name | TEGADERM? I.V. ADVANCED SECUREMENT DRESSING |
| Product Code | KMK |
| Date Received | 2018-09-06 |
| Model Number | N/A |
| Catalog Number | 1680 |
| Lot Number | 2019 07 JC |
| Device Expiration Date | 2019-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | 3M HEALTH CARE |
| Manufacturer Address | 2510 CONWAY AVE ST. PAUL MN 55144 US 55144 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2018-09-06 |