MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2020-03-26 for BARDPORT TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGL N/A 0606150CE manufactured by Bard Access Systems.
[187598184]
The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents. Based on a review of this information, the following was concluded: the complaint of a damaged port catheter was confirmed and the cause appears to be use related. The product returned for evaluation was one ti l/p implantable port with 8fr groshong catheter. The investigation findings are consistent with damage accumulated through flexural fatigue. Flexural fatigue occurs due to cyclic kinking of the catheter tube in which physiological, placement, usage, and mechanical factors may gradually form a crack(s) in the catheter. The returned product sample was evaluated and a break was observed approximately 2cm from the catheter lock. The catheter break contained physical features associated with material fatigue, and the characteristics observed which supported this type of failure included: damage which was circumferentially aligned, fracture edges which were rounded and polished due to repeated material wear, 'c' shaped impressions leading into the fracture site which are consistent with material buckling due to movement which caused the fracture edges to be pressed together, overall elliptical shape to the fracture cross-section (a result of repeated kinking of the tubing). An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product. A lot history review (lhr) of retb0104 showed one other similar product complaint(s) from this lot number.
Patient Sequence No: 1, Text Type: N, H10
[187598185]
It was reported that there was a rupture of the port. The catheter migrated to the heart. Another intervention to retrieve the catheter has been made. No reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3006260740-2020-01064 |
| MDR Report Key | 9883288 |
| Report Source | OTHER |
| Date Received | 2020-03-26 |
| Date of Report | 2020-03-26 |
| Date Mfgr Received | 2020-03-23 |
| Device Manufacturer Date | 2009-02-01 |
| Date Added to Maude | 2020-03-26 |
| 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 | PHARMACIST |
| 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 | 3 |
| Brand Name | BARDPORT TITANIUM LOW-PROFILE IMPLANTABLE PORT WITH ATTACHABLE 8F GROSHONG SINGL |
| Generic Name | PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR |
| Product Code | LJT |
| Date Received | 2020-03-26 |
| Returned To Mfg | 2019-12-02 |
| Model Number | N/A |
| Catalog Number | 0606150CE |
| Lot Number | RETB0104 |
| 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 | 1. Required No Informationntervention | 2020-03-26 |