MAUDE Adverse Event Report: BARD ACCESS SYSTEMS X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY; IMPLANTABLE PORT

Catalog Number 7707540J

Device Problems Device Contamination with Chemical or Other Material (2944); Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The lot number for the malfunction was provided; therefore, a lot history review will be performed.The sample was returned to the manufacture for inspection/evaluation.The company is still investigating the issue at this time.The device is labeled for single use.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 7707540j implanted port allegedly experienced foreign material.This information was received from one source.This malfunction did not involved patient contact.Age, weight, and gender of the patient was not provided.

Manufacturer Narrative

H10: the lot number for the malfunction was provided and a lot history review was performed.The sample was returned to the manufacture for inspection/evaluation.The sample was returned opened and the original state of the package at the time of opening could not be confirmed; therefore, the investigation was inconclusive for device contamination inside the package.A root cause has not been determined.The device was labeled for single use.H10: the reported information was re-assessed and determined to be coded as device contaminated during manufacture or shipping.H10: the catalog number identified in section d4 has not been cleared in the us, but is similar to the x-port isp with groshong catheter products that are cleared in the us.The pro code for the x-port isp with groshong catheter products is identified in d2.H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

Event Description

This report summarizes one malfunction.A review of the reported information indicated that model 7707540j implanted port allegedly experienced foreign material during manufacturing or shipping.This information was received from one source.This malfunction did not involved patient contact.Age, weight and gender of the patient was not provided.

• Brand Name: X-PORT ISP WITH GROSHONG CATHETER - JAPAN ONLY
• Type of Device: IMPLANTABLE PORT
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10290402
• MDR Text Key: 199308109
• Report Number: 3006260740-2020-02553
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 00801741098246
• UDI-Public: (01)00801741098246
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 10/15/2020

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
• Device Operator: No Information
• Device Catalogue Number: 7707540J
• Device Lot Number: REDZ0838
• Initial Date Manufacturer Received: 06/30/2020
• Initial Date FDA Received: 07/17/2020
• Supplement Dates Manufacturer Received: 09/30/2020
• Supplement Dates FDA Received: 10/15/2020
• Patient Sequence Number: 1