MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2001-08-24 for PUIC 41432 manufactured by Abbott Laboratories.
[259972]
After the submission of the initial medwatch, additional info was received from the customer which states: "the pt was acheduled for a ct and infusion solutions. Ecg, etc were being disconnected when it was noticed that there was a disconnection of the lumen of the distal catheter (the reporter himself did not disconnect the catheter, but the ect. ) the physician confirmed that no fluid loss was observed. He stated that the white clip is usually used on the ward to prevent undesired loss of blood in case no infusion is connected to the catheter. Co concludes that the disconnection must have occurred during the preparation of the pt's transport to the ct. " further additional info was received which states: "2 days after the catheter was placed, the luer-lock adapter got loose. The catheter was placed carefully, a manipulation of the adapter by the pt can be exluded. " no further info was available.
Patient Sequence No: 1, Text Type: D, B5
[19552542]
Report rec'd from abbott international (abbott-germany) of a luer lock adapter coming loose from the distal lumen of a triple lumen catheter, after two days of use. The following add'l info was rec'd: "infusing via the distal lumen was a commonly used solution containing electrolytes, amino acids, heparin, etc. The disconnection resulted in no loss of fluid. The physician was at the bedside when it happened. There was no tension on the connection. The bed was not moved at this time. The catheter was removed and a new one was inserted again. No harm to the pt. " add'l event info has been requested, but no further info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1713468-2001-00028 |
| MDR Report Key | 349593 |
| Report Source | 01,05,07 |
| Date Received | 2001-08-24 |
| Date of Report | 2001-07-20 |
| Date of Event | 2001-07-01 |
| Date Mfgr Received | 2001-07-20 |
| Date Added to Maude | 2001-09-04 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | FRANK POKROP ASSOCIATE DIRECTOR |
| Manufacturer Street | 200 ABBOTT PARK ROAD DEPT. 37K BLDG. J-45 |
| Manufacturer City | ABBOTT PARK IL 600646132 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646132 |
| Manufacturer Phone | 8479378473 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PUIC |
| Generic Name | CATHETER |
| Product Code | GBP |
| Date Received | 2001-08-24 |
| Model Number | NA |
| Catalog Number | 41432 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 338891 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | 4455 ATHERTON SALT LAKE CITY UT 84123 US |
| Baseline Generic Name | CATHETER |
| Baseline Device Family | CATHETER, MULTIPLE LUMEN |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-08-24 |