MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-03-13 for FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) N/A 5678200 manufactured by Bard Access Systems.
[138923686]
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 drawing air in the introducer needle was confirmed but the exact cause remains unknown. The product returned for evaluation was an 18ga x 2. 75" pink hub introducer needle. The returned product sample was evaluated and the luer connector was observed to be cracked. The fracture features were consistent with outward radiating forces originating within the luer hub orifice, and the characteristics observed which supported this type of failure included: a crack was observed which was longitudinally aligned. The luer threads were damaged and flared outward. Functional testing of infusion revealed a leak(s) emanating from the crack(s). Functional testing of aspiration showed that air was drawn into the syringe with test water. It was determined that the forceful insertion of a connecting device may have contributed to the observed damage; however, attempts to replicate this type of failure were unsuccessful which suggested that additional unidentified contributing factors may have also been involved. Consequently, the event was classified as cause unknown. A lot history review (lhr) of recr1630 showed no other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[138923687]
It was reported the air could not be discharged from the device. No other information was provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00545 |
| MDR Report Key | 8416643 |
| Date Received | 2019-03-13 |
| Date of Report | 2019-03-13 |
| Date of Event | 2019-02-14 |
| Date Mfgr Received | 2019-02-18 |
| Device Manufacturer Date | 2018-04-01 |
| Date Added to Maude | 2019-03-13 |
| 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, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED |
| Product Code | LFJ |
| Date Received | 2019-03-13 |
| Returned To Mfg | 2019-02-25 |
| 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 | 2019-03-13 |