MAUDE Adverse Event Report: BARD ACCESS SYSTEMS WHITE ADAPTER LEG FOR HICKMAN AND LEONARD MULTIPLE LUMEN CV CATHETERS REPAIR KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	0601680
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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.
Event or Problem Description
It was reported that the facility has alleged the catheter has holes in the tubing, small splits in the tubing and/or separation at the repair kit.Device was removed.There was no patient injury.
Event or Problem Description
It was reported that the facility has alleged the catheter has holes in the tubing, small splits in the tubing and/or separation at the repair kit.Device was removed and replaced.There was no patient injury.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 6.6 fr s/l broviac external red hub extension tube set segment was returned for evaluation.During gross examination, it was noted that the detailing was worn off the protective clamping sleeve and a partial circumferential split was noted on the lumen approximately 0.4cm from the distal end of the luer.The sample was patent to infusion with leaking noted at the site of the split.When viewed under magnification, the edges of the split were noted to be jagged.Based on the findings, the investigation is confirmed for the reported leak.Per the evaluation results, the lumen was split very close to the distal end of the luer and wear was noted to the protective clamping sleeve, indicating that clamping the catheter adjacent to the crimp collar may have contributed to the reported event.Clamping in this region compresses the catheter material between the harder materials of the clamp and the luer hub stem, resulting in catheter damage.While a definitive root cause could not be determined based upon available information, it is possible that procedural issues contributed to the reported event.Labeling review: the instructions for use (ifu) that was included with the product prescribes the proper method of implantation for this device to prevent undue injury to the patient and damage to the product.On site care instructions states to use alcohol wipes during cleanings.This ifu warns: do not use the catheter if there is any evidence of mechanical damage or leaking.Accessories and used in conjunction with this device should incorporate luer lock connectors.Avoid accidental device contact with sharp instruments and mechanical damage to the catheter material.Use only smooth edge atraumatic clamps or forceps.Avoid perforating, tearing or fracturing the catheter when using a guidewire.

• Brand Name: WHITE ADAPTER LEG FOR HICKMAN AND LEONARD MULTIPLE LUMEN CV CATHETERS REPAIR KIT
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7535507
• Report Number: 3006260740-2018-01041
• Device Sequence Number: 945493
• Product Code: LJS
• UDI-Device Identifier: 00801741036415
• UDI-Public: (01)00801741036415
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830406
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2018

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: 08/31/2020
• Device Model Number: 0601680
• Device Catalogue Number: 0601680
• Device Lot Number: REBY0454
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Initial Date Received by Manufacturer: 05/08/2018
• Supplement Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 12/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR