MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR. S/L POWERPICC - RADIOLOGY, STANDARD, 70 CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number 3174155

Device Problems Fluid/Blood Leak (1250); Material Integrity Problem (2978)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reav1448 showed no other similar product complaint(s) from this lot number.Device, not yet returned.

Event Description

It was reported that "drilling" was detected in the material causing leakage.No other information has been provided.

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 a leak within the powerpicc catheter is confirmed, and the cause appears to be use-related.The device returned was one powerpicc 4fr s/l catheter.Visual observation found signs of use and a large longitudinal split in the region of the 20-cm depth mark, about 1.8 cm in length.Whitish particulate was found inside the lumen at this split, and some fell out during evaluation.Tactual evaluation found some hard material within the lumen distal to the split.While infusion proximal to the split was not difficult, infusion distal to the split was very difficult and only a small amount of flow was achieved.Microscopic evaluation found that the material was stretched near the center of the split and the break surface was granular.There was a particularly rough texture at a point of the break somewhat near the center of the split.These break characteristics are typical of burst damage due to overpressurization.The distal end of the catheter manifested a blockage of yellowish material which may have contributed to resistance encountered during flushing.The wall thickness of the tubing was measured and not found to be outside of specification.The complaint is confirmed and appears to be use-related.The ifu states the following: ¿contrast media should be warmed to body temperature prior to power injection.Warning: failure to warm contrast media to body temperature prior to power injection may result in catheter failure.Vigorously flush the powerpicc* catheter using a 10 ml or larger syringe and sterile normal saline prior to and immediately following the completion of power injection studies.In addition, lock each lumen of the catheter with heparinized saline.Usually one ml per lumen is adequate.This will ensure the patency of the powerpicc* catheter and prevent damage to the catheter.Resistance to flushing may indicate partial or complete catheter occlusion.Do not proceed with power injection study until occlusion has been cleared.Warning: failure to ensure patency of the catheter prior to power injection studies may result in catheter failure.Do not exceed the maximum flow rate of 5 ml/sec.Warning: power injector machine pressure limiting feature may not prevent over pressurization of an occluded catheter, which may cause catheter failure.Warning: exceeding the maximum flow rate of 5 ml/sec, or the maximum pressure of power injectors of 300 psi, may result in catheter failure and/or catheter tip displacement.Warning: powerpicc* catheter indication for power injection of contrast media implies the catheter¿s ability to withstand the procedure, but does not imply appropriateness of the procedure for a particular patient.A suitably trained clinician is responsible for evaluating the health status of a patient as it pertains to a power injection procedure.¿ ¿catheter maintenance.Flush each lumen of the catheter with 10 ml saline every 12 hours or after each use.In addition, lock each lumen of the catheter with heparinized saline.Usually, one ml per lumen is adequate.¿ a lot history review (lhr) of reav1448 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that "drilling" was detected in the material causing leakage.No other information has been provided.

• Brand Name: 4 FR. S/L POWERPICC - RADIOLOGY, STANDARD, 70 CM
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• 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: 7070698
• MDR Text Key: 93717670
• Report Number: 3006260740-2017-02164
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027611
• UDI-Public: (01)00801741027611
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K070996
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

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
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: 3174155
• Device Catalogue Number: 3174155
• Device Lot Number: REAV1448
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/30/2017
• Supplement Dates Manufacturer Received: 01/23/2018
• Supplement Dates FDA Received: 02/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2016
• 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