MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2018-12-21 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.
[131191682]
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint that the guidewire became stuck in the introducer needle was confirmed and the damage appeared to be related to use of the device. One 0. 038? Guidewire was received within an 18g introducer needle. The distal tip of the guidewire was lodged in the needle. The guidewire was not extending from the distal tip of the introducer needle. A microscopic examination of the 18g introducer needle revealed that the inner edge of the opening at the needle bevel was deformed. Blood residue was visible within the needle. It was noted that the core wire broke at the distal weld tip, which allowed the coil wire to stretch over the core wire. The guidewire was forcefully pulled from the introducer needle. Biological material was found on the section of coil wire that was within the introducer needle. The damage at the needle bevel and the presence of biological residue lodged between the guidewire and needle indicate that the guidewire was retracted within the introducer needle. The outside diameter (od) of the guidewire was found to be within specification. The product ifu cautions,? Do not pull back guidewire over needle bevel as this may sever the end of the guidewire. The introducer needle must be removed first. Also, if unusual resistance is met during manipulation of the guidewire, discontinue the procedure and determine the cause of resistance before proceeding. Withdraw needle and guidewire if cause of resistance cannot be determined.? A lot history review (lhr) of recr1630 showed one other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[131191683]
The guidewire stuck with the needle while insertion (inside the needle). On (b)(6) 2018, per sample evaluation, the core wire broke at the distal weld tip.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2018-03648 |
| MDR Report Key | 8189400 |
| Report Source | COMPANY REPRESENTATIVE |
| Date Received | 2018-12-21 |
| Date of Report | 2018-12-20 |
| Date of Event | 2018-10-18 |
| Date Mfgr Received | 2018-12-04 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2018-12-21 |
| 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 | KELSEY ERICKSON |
| Manufacturer Street | 605 N. 5600 W. |
| Manufacturer City | SALT LAKE CITY UT 84116 |
| Manufacturer Country | US |
| Manufacturer Postal | 84116 |
| Manufacturer Phone | 8015225937 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. -9617592 |
| Manufacturer Street | BLVD. MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA, TAMAULIPAS |
| Manufacturer Country | MX |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2018-12-21 |
| Returned To Mfg | 2018-11-21 |
| Model Number | N/A |
| Catalog Number | 5678200 |
| Lot Number | RECR1630 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD ACCESS SYSTEMS |
| Manufacturer Address | 605 N. 5600 W. SALT LAKE CITY UT 84116 US 84116 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-12-21 |