MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a consumer,distributor,other report with the FDA on 2020-02-26 for ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 30BX 37303 manufactured by C.r. Bard, Inc. (covington) -1018233.
[184332971]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[184332972]
It was reported that the patient said the adhesive had? Gone down,? Which caused the externals to come off at night. He also said they would come off in the shower, cause pain, make his skin red and blue, and leave adhesive on his skin. Per follow up with the customer on 5feb2020, the adhesive was still stuck on the patient again. It was unknown if he received medical intervention. He tried the 32303 samples and liked them. Per follow up with the customer on 11feb2020, the customer experienced bleeding while using this mec. It was unknown if he received medical intervention. Per follow up with the customer on 14feb2020, the external catheters were leaking due to a lack of adhesive.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01385 |
| MDR Report Key | 9759173 |
| Report Source | CONSUMER,DISTRIBUTOR,OTHER |
| Date Received | 2020-02-26 |
| Date of Report | 2020-03-29 |
| Date Mfgr Received | 2020-03-17 |
| Date Added to Maude | 2020-02-26 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ROCHESTER MEC SPIRIT SHEATH STYLE 2 POP 32MM 30BX |
| Generic Name | MEC |
| Product Code | NNX |
| Date Received | 2020-02-26 |
| Model Number | 37303 |
| Catalog Number | 37303 |
| Lot Number | UNK |
| Operator | LAY USER/PATIENT |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-26 |