MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOGLIDE PC-2 DIALYSIS CATHETER KIT 28CM (14.5F) (LONG-TERM) (EXPORT ONLY); BLOOD ACCESS AND ACCESSORIES

Model Number	N/A
Health Effect - Clinical Code	Blood Loss (2597)
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; the manufacturing lot number that was provided is incorrect.A lot history review (lhr) of reve1110 showed no other similar product complaint(s) from this lot number.Device not yet returned for evaluation.
Event or Problem Description
It was reported that the patient had done some pd in the morning and was having a 2 hour hd session following his pd training.He had been dialyzing for approximately 1 hour.It was stated the healthcare professionals (hcps) then attended to his dressing, when they noticed it was leaking at the hub, the hcps ceased hd and clamped above the split.The hcps also noticed a moderate amount of blood on the patient where we assume it had been bleeding.The line was removed from the patient.No patient harm was reported.
Additional 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 was of a leak in the catheter was confirmed, and the damage appears to be associated with use of the device.The proximal segment of a 28cm hemoglide catheter was returned for investigation.The catheter extended 5.0 cm from the distal end of the bifurcation.The catheter exhibited evidence of use.What appeared to be residue from the dressing remained adhered to the extension legs, bifurcation, and d/l tubing.The d/l tubing, bifurcation, extension legs, and clamp tags were discolored.A semi-circumferential crease was observed in the d/l tubing 5mm from the distal end of the bifurcation.It appeared that the catheter was kinked.A functional test confirmed a leak in the catheter at the distal end of the bifurcation.A breach in the tubing allowed fluid to leak from the arterial lumen when the catheter was pressurized.A microscopic examination of the leak site revealed catheter material that was rough and granular, which is indicative of a tear.The tear in the tubing may be attributable to mechanical stresses and possibly chemical degradation.As it was reported that the catheter was in place for 4 months, the hole in the tubing developed over time and occurred during use.
Event or Problem Description
It was reported that the patient had done some pd in the morning and was having a 2 hour hd session following his pd training.He had been dialyzing for approximately 1 hour.It was stated the healthcare professionals (hcps) then attended to his dressing, when they noticed it was leaking at the hub, the hcps ceased hd and clamped above the split.The hcps also noticed a moderate amount of blood on the patient where we assume it had been bleeding.The line was removed from the patient.No patient harm was reported.

• Brand Name: HEMOGLIDE PC-2 DIALYSIS CATHETER KIT 28CM (14.5F) (LONG-TERM) (EXPORT ONLY)
• 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: 6642372
• Report Number: 3006260740-2017-00778
• Device Sequence Number: 16366975
• Product Code: MSD
• UDI-Device Identifier: 00801741012631
• UDI-Public: (01)00801741012631(17)160614(10)REVE1110
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K010567
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2017

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 Expiration Date: 06/14/2016
• Device Model Number: N/A
• Device Catalogue Number: 5664230
• Device Lot Number: REVE1110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 08/01/2017
• Initial Report FDA Received Date: 06/14/2017
• Supplement Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1