MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT STC PPICC MAX, SOLO 5 FR TL, FULL W/TCS; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number 1395108QD

Device Problems Fluid/Blood Leak (1250); Insufficient Flow or Under Infusion (2182); Malposition of Device (2616)

Patient Problem Blood Loss (2597)

Event Date 06/24/2017

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 device has not been returned to the manufacturer for evaluation, as the device is being retained by the reporting facility.A lot history review (lhr) review is not possible; the manufacturing lot number that was provided is incorrect.

Event Description

It was reported by the facility, via the sales rep, that the bedside nurse reported an occluded picc to the picc team.The picc nurse assessed the right basilic picc, changed injection caps, and flushed.The picc nurse was able to flush all three lumens, but only got intermittent blood return from two of the three lumens (red and gray).She suspected the picc had malposition to the right ij, but the patient was very agitated so chest x-ray was delayed.The bedside nurse called again twenty minutes later saying that there was blood drainage at the insertion site.The x-ray had been completed then and showed the tip in the lower svc to acj.On assessing the site the second time, she noted a saturated guardiva patch.Under the dressing there was blood and "milky" drainage.The patient was on a propfol drip for sedation, which is a milky white.This caused the nurse to suspect catheter damage.She started a peripheral iv and gave propfol through it and the patient immediately calmed.She removed the picc line and was able to clearly see a rupture at the 5 cm marking.There was a small amount of swelling to his upper arm, but his medications were low volume.A picc had to be placed in the patient's left arm.No patient injury was 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 an occluded and damaged catheter was confirmed and the cause was determined to be use related.The product returned for evaluation was a 5fr t/l powerpicc solo catheter.The sample contained red usage residue throughout and two parallel splits in the catheter were found at the 5cm depth marking.The splits were adjacent to each other and were the same length.Further examination showed that each split was associated with either small lumen of the catheter.Additionally, a region of catheter was found at the 14cm depth marking which was ballooned in nature.Functional testing showed that the catheter was occluded through both small lumens immediately distal to both splits.Additionally, the catheter was found to be occluded immediately distal to the ballooned region of catheter.Microscopic examination of the catheter splits showed that the fracture surfaces were dull and granular in nature and that the catheter material had been stretched on either side of both splits.The observed damage was characteristic of catheter over-pressurization (burst) damage.This can occur through the use of syringes smaller than 10ml, by flushing against an occlusion, or due to excessive force applied during infusion procedures.The observed occlusions were found to be related to infusate buildup and were likely associated with the bursts due to the location of the bursts.An examination of the catheter revealed no potential damage/defect related to manufacture of the product.

Event Description

It was reported by the facility, via the sales rep, that the bedside nurse reported an occluded picc to the picc team.The picc nurse assessed the right basilic picc, changed injection caps, and flushed.The picc nurse was able to flush all three lumens, but only got intermittent blood return from two of the three lumens (red and gray).She suspected the picc had malposition to the right ij, but the patient was very agitated so chest x-ray was delayed.The bedside nurse called again twenty minutes later saying that there was blood drainage at the insertion site.The x-ray had been completed then and showed the tip in the lower svc to acj.On assessing the site the second time, she noted a saturated guardiva patch.Under the dressing there was blood and "milky" drainage.The patient was on a propfol drip for sedation, which is a milky white.This caused the nurse to suspect catheter damage.She started a peripheral iv and gave propfol through it and the patient immediately calmed.She removed the picc line and was able to clearly see a rupture at the 5 cm marking.There was a small amount of swelling to his upper arm, but his medications were low volume.A picc had to be placed in the patient's left arm.No patient injury was reported.

• Brand Name: DOT STC PPICC MAX, SOLO 5 FR TL, FULL W/TCS
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• 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: 6723316
• MDR Text Key: 80557400
• Report Number: 3006260740-2017-01075
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741034725
• UDI-Public: (01)00801741034725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091324
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2017,09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1395108QD
• Device Catalogue Number: 1395108QD
• Device Lot Number: REBR_4021 (INVALID)
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2017
• Distributor Facility Aware Date: 06/24/2017
• Event Location: Hospital
• Date Report to Manufacturer: 06/25/2017
• Date Manufacturer Received: 08/24/2017
• 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