MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOGLIDE KIT, PC-2; BLOOD ACCESS AND ACCESSORIES

Catalog Number	5664190
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional 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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned, at this time.
Event or Problem Description
It was reported on (b)(6) 2017, that the catheter lumen appeared to be partially separated from the triangle hub causing a leak.There was no reported patient injury.
Additional 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 following were reviewed as part of this investigation: patient severity, trend 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 partially separated dialysis catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one hemoglide precurve dialysis catheter.Usage residues were abundant throughout the sample.The extension tubing and molded joint markings were completely worn.The catheter tubing, extension tubing and molded joint were discolored.Biological residue was observed throughout the tissue ingrowth cuff.A partially circumferential split was observed at the junction between the catheter tubing and the molded joint.Tactile inspection of the sample revealed tensile weakness in the vicinity of the split.The tubing also exhibited increased pliability in the vicinity of the leak when compared to a similar non-complainant device.Microscopic inspection of the split revealed a dully granular fracture surface.Material discoloration was observed in the vicinity of the split.The increased pliability and tensile weakness were typical of repeated sample manipulation.The split characteristics were consistent with material fatigue caused by such manipulation.The extensive discoloration suggested repeated chemical contact.It was unclear if such chemical exposure contributed to the observed damage.

• Brand Name: HEMOGLIDE KIT, PC-2
• Common Device Name: BLOOD ACCESS AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6393069
• Report Number: 3006260740-2017-00215
• Device Sequence Number: 34650
• Product Code: MSD
• UDI-Device Identifier: 00801741012624
• UDI-Public: (01)00801741012624
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2017

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: Health Professional
• Device Catalogue Number: 5664190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/09/2017
• Supplement Report FDA Received Date: 04/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1