MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN BROVIAC CATHETER; UNKNOWN CHRONIC CATHETER

Catalog Number UNKNOWN

Device Problems Difficult to Flush (1251); Aspiration Issue (2883); Torn Material (3024)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported by the facility that they were unable to aspirate from the central venous line and it was difficult to flush.While attempting to flush the catheter the tubing tore.Patient was taken to the operating room for replacement.No patient injury reported.

Manufacturer Narrative

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 torn catheter was confirmed and the cause appears to be use related.The product returned for evaluation was 2.7 fr broviac catheter.The damage observed in the returned sample was characteristic of 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 returned product sample was evaluated and a split was observed 14 mm distal of the clamping oversleeve.This catheter damage was typical of a burst, and the characteristics observed which supported this type of failure included: 's' shaped split.Tensile weakness at the fracture site (due to material ballooning prior to burst).Granular fracture surface texture (typical of tearing failure modes).An occlusion was observed distal to the burst site, and this may have contributed to the failure.Forceful flushing against an occlusion can cause this type of failure.The nursing procedure manual can be found online at www.Bardaccess.Com and provides the following guidance: ¿do not use a syringe smaller than 10ml to flush or confirm patency.Patency should be assessed with a 10ml or larger syringe with sterile saline.Upon confirmation of patency, administration of medication should be given in a syringe appropriately sized for the does.Do not infuse against resistance.Infusion pressures should never exceed 25 psi.Smaller syringes generate more pressure than larger syringes.¿ the nursing procedure manual also provides guidance for re-establishing catheter patency in the event the catheter becomes occluded or resistance is felt during flushing.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported by the facility that they were unable to aspirate from the central venous line and it was difficult to flush.While attempting to flush the catheter the tubing tore.Patient was taken to the operating room for replacement.No patient injury reported.

• Brand Name: UNKNOWN BROVIAC CATHETER
• Type of Device: UNKNOWN CHRONIC CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 7334921
• MDR Text Key: 102334627
• Report Number: 3006260740-2018-00419
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 01/01/2018,06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/21/2018
• Date Manufacturer Received: 05/08/2018
• 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