MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2019-02-14 for SOFT-CELL STRAIGHT CHRONIC DUAL-LUMEN CATHETER KIT 5534190 manufactured by Bard Access Systems.
[136249516]
Manufacturing review: the device history records have been reviewed and this lot met all release criteria. There was nothing found to indicate there was a manufacturing related cause for this event. This is the only complaint reported to date for this lot number and failure mode. Investigation summary:one guidewire (with guidewire straightener and hoop) and one introducer needle were returned for evaluation. It was noted that the guidewire was bent with its outer coil wire stretched at the distal end. When viewed under magnification, slight wear was noted to the needle bevel. The guidewire could not be inserted into the introducer needle due to the identified stretching. Based on these findings, the investigation is confirmed for the reported guidewire advancement issue, specifically due to a frayed guidewire. Per the evaluation results, wear was noted to the needle bevel. This can occur as a result of retraction of the guidewire against the needle bevel. Therefore, it's possible that the guidewire was damaged as a result of retraction against the needle bevel. However, the definitive root cause could not be determined based upon available information. It is unknown whether patient and/or procedural issues contributed to the reported event. Labeling review:the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiration date: 07/2021).
Patient Sequence No: 1, Text Type: N, H10
[136249517]
It was reported that during the procedure the guidewire became allegedly stuck, therefore, the health care provider attempted to manipulate the guidewire unsuccessfully. Reportedly, the device was removed. Another kit was opened to complete the procedure. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00280 |
| MDR Report Key | 8341781 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-02-14 |
| Date of Report | 2019-02-14 |
| Date of Event | 2018-10-19 |
| Date Mfgr Received | 2019-01-18 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2019-02-14 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1625 W 3RD ST. |
| Manufacturer City | TEMPE AZ 85281 |
| Manufacturer Country | US |
| Manufacturer Postal | 85281 |
| Manufacturer Phone | 4803032689 |
| Manufacturer G1 | BARD REYNOSA S.A. DE C.V. |
| Manufacturer Street | BLVD MONTEBELLO #1 PARQUE INDUSTRIAL COLONIAL |
| Manufacturer City | REYNOSA TAMAULIPAS 88780 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 88780 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SOFT-CELL STRAIGHT CHRONIC DUAL-LUMEN CATHETER KIT |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LFJ |
| Date Received | 2019-02-14 |
| Returned To Mfg | 2018-11-21 |
| Model Number | 5534190 |
| Catalog Number | 5534190 |
| Lot Number | RECU0622 |
| 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 | 2019-02-14 |