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 2020-03-19 for POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL 8808560 manufactured by Bard Access Systems.
[184755646]
Manufacturing review: a complete manufacturing review could not be conducted for the investigation as the lot number is unknown. Investigation summary: one x-port isp with cath-lock and groshong catheter were returned for evaluation. Visual, microscopic and functional testing were performed. A complete circumferential break was noted on the proximal end of the catheter. A circumferential split was noted 8. 0mm from the proximal end of the catheter segment. The catheter measured approximately 7. 8cm in length. The distal end was granular and elliptical in shape which are typical characteristics of a failure by pinch off that can sometimes lead to aspiration failure as it was alleged in the complaint at hand. An image review was performed and it also revealed an embolism of the catheter. The tubing was observed to have a medial insertion into the subclavian vein. The investigation is confirmed for the alleged aspiration failure, specifically due to the pinch off of the catheter. Labeling review: a review of product labeling documents (e. G. Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
Patient Sequence No: 1, Text Type: N, H10
[184755647]
It was reported that some time post port placement, an x-ray was performed and revealed that the catheter allegedly appeared stretched and damaged. Therefore, the device was removed. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-00934 |
| MDR Report Key | 9857813 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-19 |
| Date of Event | 2019-06-05 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-19 |
| 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 | JUDITH LUDWIG |
| Manufacturer Street | 1415 W. 3RD STREET |
| 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 | POWER PORT MRI ISP, 8FR. GROSHONG, INT W SP, ATTACHABLE SL |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-19 |
| Returned To Mfg | 2020-02-24 |
| Catalog Number | 8808560 |
| Lot Number | UNKNOWN |
| 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 | 2020-03-19 |