MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN HEMOSTAR; HEMODIALYSIS

Model Number N/A

Device Problem Torn Material (3024)

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

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

During evaluation bas engineers found a slit distal to the cuff of the catheter.

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 report of a slit in the catheter is confirmed, and the cause is determined to be likely use-related.The samples returned were one 19 cm hemostar dialysis catheter and one photograph of the device as inserted in the patient.The photograph showed the device inserted into the patient, with no bleeding apparent.Visual observation confirmed the discoloration reported in the original complaint.There was clear accumulation of biological material on the cuff.A transverse slit in the catheter was found on the venous side of the catheter just distal to the cuff.Some solid residue was found inside the lumen exposed by the slit.Functional testing found both lumens patent to infusion, and that the venous lumen would leak during infusion from the slit next to the cuff.Microscopic observation found that the slit edges were very clean, and the slit was straight for the majority of its length.If the slit had been present in the catheter during dialysis, it would have resulted in significant bleeding, and if not present during dialysis but during use, it would likely have caused noticeable bleeding.However, it was not mentioned in the original complaint, and was therefore likely caused during or after removal.The slit has the appearance of a cut with a sharp instrument, and being distal to the cuff, this is suggestive of being caused during the loosening of the cuff during removal, during which procedure a sharp instrument may be used for trimming tissue away from the cuff.However, it appears that in conjunction with a similar event for a similar device reported in complaint (b)(4), from the same facility, based on information from the customer, a cut was made at the extension leg in order to identify the white material composing the discoloration.Therefore, it is considered possible that this cut was made intentionally by the user.

Event Description

During evaluation bas engineers found a slit distal to the cuff of the catheter.

• Brand Name: UNKNOWN HEMOSTAR
• Type of Device: HEMODIALYSIS
• 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: 6713654
• MDR Text Key: 80143499
• Report Number: 3006260740-2017-01039
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 08/28/2017
• 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