MAUDE Adverse Event Report: BARD ACCESS SYSTEMS TI POWER PORT ISP; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Model Number	1708050
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot met all release criteria.Manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.One of the devices was returned for evaluation.One 8fr chronoflex catheter and one ti powerport isp and various kit components were returned for evaluation.Visual, tactual, and functional evaluations were performed.The investigation is unconfirmed for a hole in the catheter, as the port body and catheter were separately patent to infusion, aspiration, and infusion against resistance and no leaks were observed, and no obvious damage was visually observed throughout the catheter or port body.Although the complaint was unconfirmed and therefore a definitive root cause could not be determined, sharp instrument or other mechanical damage could have potentially caused or contributed to such an incident as that reported.For the malfunction in which the device was not returned, the investigation is inconclusive for as no objective evidence has been provided to confirm any alleged deficiency with the device.Based upon the available information, the definitive root cause is unknown.The device is labeled for single use.
Event or Problem Description
This report summarizes two malfunctions.A review of the reported information indicated that model 1708050 implantable port allegedly leaked.One of the devices was unable to be used and was replaced.There was no reported patient injury.This information was received from various sources.The age of the patients ranged from 2 years to 65 years.Both patients were female and the weight was not provided.

• Brand Name: TI POWER PORT ISP
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8818892
• Report Number: 3006260740-2019-02132
• Device Sequence Number: 3109695
• Product Code: LJT
• UDI-Device Identifier: 00801741026591
• UDI-Public: (01)00801741026591
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Model Number: 1708050
• Device Catalogue Number: 1708050
• Device Lot Number: RECX3458
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2019
• Initial Report FDA Received Date: 07/23/2019
• Patient Sequence Number: 1