MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN DIALYSIS; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number UNKNOWN

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2017

Event Type  malfunction  

Manufacturer Narrative

The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that the equistream was implanted in (b)(6) 2016, no reported problems.On (b)(6) 2017, during dialysis in the external dialysis center, blood was vented at the venous limb below the hard connecting piece of the limbs during dialysis.The patient was sent to the hospital.The catheter was removed and replaced by physician.There was no patient injury reported.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed and was determined to be use related.One segment of a 23 cm eqiustream catheter was returned for evaluation.An initial visual observation showed use residue throughout the sample.Both extension legs were observed to be indented in many locations along their length, and the ink on the extension legs was observed to be worn and faded.Both lumens of the sample were flushed with a 12 ml syringe of water and were both found to be patent to infusion and aspiration.The distal end of the sample was then clamped with atraumatic clamps and then the catheter was pressurized with the 12 ml syringe of water.A leak was observed emanating from the junction between the blue lumen and the bifurcation.A microscopic observation revealed a split between the bifurcation and extension leg of the blue lumen.Deep and patterned striations were observed on the surface of the break, and strings of what appeared to be the tubing material were observed between the break surfaces.The nature of the break surfaces as well as the location of the break are evidence of material fatigue due to repeated stretching of the extension tubing at this point.No further action is required because the reported event could not be related to a deficiency in product manufacture or deficiency while under correct product use.

Event Description

It was reported that the equistream was implanted in (b)(6) 2016, no reported problems.On (b)(6) 2017, during dialysis in the external dialysis center, blood was vented at the venous limb below the hard connecting piece of the limbs during dialysis.The patient was sent to the hospital.The catheter was removed and replaced by physician.There was no patient injury reported.

• Brand Name: UNKNOWN DIALYSIS
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6769200
• MDR Text Key: 81918639
• Report Number: 3006260740-2017-01226
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Dialysis Center
• Date Manufacturer Received: 08/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1