MAUDE Adverse Event Report: BARD ACCESS SYSTEMS BARD PICC; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problems Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)

Patient Problems Bruise/Contusion (1754); Fall (1848); No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned, at this time, to the manufacturer for evaluation.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 that the picc was split.Epileptic patient collapsed to the floor, bruising her picc arm.Her carer flushed the picc later that evening and it leaked.Picc removed and a split was discovered between 12 and 13 cm.Dwell time 145 days.Used for occasional anti-epileptic medicine (not including phenytoin).

Event Description

It was reported that the picc was split.Epileptic patient collapsed to the floor, bruising her picc arm.Her carer flushed the picc later that evening and it leaked.Picc removed and a split was discovered between 12 and 13 cm.Dwell time 145 days.Used for occasional anti-epileptic medicine (not including phenytoin).

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), applicable fmea documents, labeling, and applicable manufacturing records.Based on a review of this information, the following was concluded: the complaint of a leak is confirmed but the exact cause could not be determined from the photo sample provided.One photo sample of a powerpicc catheter was returned for investigation.The winged hub and the luer connector are not shown.The catheter is showed being manipulated to show it to be kinking with a split present.The split surface characteristics cannot be clearly observed.The event description indicates the patient collapsed causing injury to their arm and that the catheter dwell time was 145 days.Based on the photo sample provided and description of the reported event, possible contributing factors include tensile damage, material fatigue, and over-pressurization.Since the exact cause could not be determined from the photo, the complaint is confirmed, cause unknown.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• Brand Name: BARD PICC
• 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
• MDR Report Key: 8437187
• MDR Text Key: 139548802
• Report Number: 3006260740-2019-00608
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/02/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1