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 2019-03-25 for SFTCEL-PC RJ 19CM KIT 5534190 manufactured by Bard Access Systems.
[139805195]
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. Investigation summary: one guidewire and one introducer needle were returned for evaluation. The guidewire was received inserted in the introducer needle. The guidewire was able to be removed from the needle, with residue noted on the portion of the guidewire that had been inside the needle. When viewed under magnification, unraveling/stretching of the outer coil wire was noted near the residue. Based on this finding, the investigation is confirmed for the reported advancement issue, specifically due to a frayed guidewire. 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. Potential contributing factors include insertion technique, insufficient-sized skin nick and retraction against the introducer needle bevel. 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. (expiry date: 07/2021).
Patient Sequence No: 1, Text Type: N, H10
[139805196]
It was reported that during placement of dialysis catheter, the guidewire allegedly was unable to advance through the introducer needle. It was further reported that the introducer needle and the guidewire were removed together. Reportedly, another introducer needle and guidewire was used to placed the initial dialysis catheter provided in the kit. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2019-00670 |
| MDR Report Key | 8450148 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2019-03-25 |
| Date of Report | 2019-03-25 |
| Date of Event | 2019-01-16 |
| Date Mfgr Received | 2019-03-08 |
| Device Manufacturer Date | 2018-07-18 |
| Date Added to Maude | 2019-03-25 |
| 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 | SFTCEL-PC RJ 19CM KIT |
| Generic Name | SOFT CELL D/L DIALYSIS |
| Product Code | LFJ |
| Date Received | 2019-03-25 |
| Returned To Mfg | 2019-02-12 |
| 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 | 2019-03-25 |