MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-31 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.
[134712643]
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 of a stuck guidewire within the needle is confirmed and appears to be related to the use of the device. One guidewire and hoop were returned with the distal end of the wire within the introducer needle. The guidewire was observed to be elongated and uncoiled. Use residue was observed throughout the sample. Microscopic observation of the needle bevel revealed material damage consistent with retraction of the guidewire against the bevel. Force was required to remove the guidewire from the needle. The core wire was observed to be frayed. The distal weld tip was present. The ifu cautions,? Caution: 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 recu0723 showed two other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[134712644]
It was reported that the wire was stuck in the needle. No other information was provided. On (b)(6) 2018: the core wire from the guidewire was observed to be frayed on the returned sample.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00136 |
| MDR Report Key | 8295225 |
| Date Received | 2019-01-31 |
| Date of Report | 2019-01-31 |
| Date of Event | 2018-11-15 |
| Date Mfgr Received | 2019-01-11 |
| Device Manufacturer Date | 2018-07-01 |
| Date Added to Maude | 2019-01-31 |
| 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 | 0 |
| Brand Name | FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) |
| Generic Name | CATHETER, SUBCLAVIAN |
| Product Code | LFJ |
| Date Received | 2019-01-31 |
| Returned To Mfg | 2019-01-02 |
| Model Number | N/A |
| Catalog Number | 5678200 |
| Lot Number | RECU0723 |
| 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 | 2019-01-31 |