MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-12-16 for TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER SET C-TAPS-9.5-31-12-0-10.5 manufactured by Cook Inc.
[130635933]
The field for sections was not populated due to a technical limitation: common name: catheter, peritoneal; product code: gbw. This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable. Additional complaint investigation and record remediation was not performed.
Patient Sequence No: 1, Text Type: N, H10
[130635934]
It was reported that during the peritoneal dialysis, a luer lock connection on tenckhoff acute peritoneal dialysis catheter was leaking when connected o another manufacturer's dialysis bag. The luer lock was not a "snug fit" with the other manufacturer's kit. There were no adverse effects reported due to the event and no report of an additional procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1820334-2018-03821 |
| MDR Report Key | 8167876 |
| Date Received | 2018-12-16 |
| Date of Report | 2018-12-16 |
| Date Mfgr Received | 2018-12-13 |
| Device Manufacturer Date | 2014-07-21 |
| Date Added to Maude | 2018-12-16 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LARRY POOL |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal | 47404 |
| Manufacturer Phone | 8128294891 |
| Manufacturer G1 | COOK INC |
| Manufacturer Street | 750 DANIELS WAY |
| Manufacturer City | BLOOMINGTON IN 47404 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 47404 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER SET |
| Product Code | GBW |
| Date Received | 2018-12-16 |
| Model Number | NA |
| Catalog Number | C-TAPS-9.5-31-12-0-10.5 |
| Lot Number | 5112104 |
| Device Expiration Date | 2017-07-21 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COOK INC |
| Manufacturer Address | 750 DANIELS WAY BLOOMINGTON IN 47404 US 47404 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-16 |