MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-29 for FLEXXICON DIALYSIS CATHETER KIT 11F X 15CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678150 manufactured by Bard Access Systems.
[146648763]
The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a guidewire stuck within an introducer needle was confirmed and the cause was determined to be use related. The products returned for evaluation were one 0. 035 in. J-tip guidewire in a plastic hoop and one 18 g introducer needle. The investigation findings are consistent with damage caused by retraction of the guidewire against the bevel of the introducer needle. The returned product sample was evaluated and the guidewire was confirmed to be broken with the coil wire being unraveled. It appeared that the inner core wire had broken which allowed the outer coil wire surrounding it to unravel. Microscopic examination of the fracture sites revealed the following: narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire. Damage to the inside edge of the introducer needle which can occur if the guidewire is forcefully retracted against the needle, damaging the shape of the sharpened bevel. Biological material was also seen on the wire which may have contributed to the observed guidewire fracture as retraction of the wire together with the biological material could have caused the pieces to become stuck. Normal movement of the guidewire is away from the sharpened bevel and will not damage the wire. If the guidewire direction is reversed, the guidewire is then pulled against the sharpened edge of the needle bevel and can cause shearing damage of the wire and/or cause the wire to become stuck within the needle. An examination of the wire structure revealed no potential damage/defect related to manufacture of the product. 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 recv2525 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[146648764]
It was reported that the needle stuck with guide wire. On (b)(6) 2019- returned wire was broken with the coil wire unraveled.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-01490 |
| MDR Report Key | 8649686 |
| Date Received | 2019-05-29 |
| Date of Report | 2019-05-29 |
| Date of Event | 2019-03-28 |
| Date Mfgr Received | 2019-05-10 |
| Device Manufacturer Date | 2018-08-01 |
| Date Added to Maude | 2019-05-29 |
| 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 | 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 15CM (SHORT-TERM) (DUAL-LUMEN) |
| Generic Name | CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | LFJ |
| Date Received | 2019-05-29 |
| Returned To Mfg | 2019-04-30 |
| Model Number | N/A |
| Catalog Number | 5678150 |
| Lot Number | RECV2525 |
| 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 | 2019-05-29 |