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

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 10/11/2018

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 there was a split in the picc.The split was discovered by the rn when dressing was to be done.There was no reported patient injury.

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 in the picc was confirmed, and it appeared that the damage was associated with used of the device.One 6fr triple lumen powerpicc solo was returned for investigation.The catheter extended to the 53cm depth mark.A 1.5cm long slit was observed in the tubing at the 5cm depth mark.The slit exposed the power injectable lumen.A microscopic examination of the slit revealed that the adjoining surfaces of the tubing were striated and the edges of the tubing along the slit were sharp and clearly defined.The observed damage is consistent with the tubing being cut with a sharp instrument.Since use residue was observed in the catheter, it appears that the damage occurred while the picc was in place.It was reported that the split was discovered when the dressing was to be done.The product ifu indicates that accidental device contact with sharp instruments should be avoided.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 there was a split in the picc.The split was discovered by the rn when dressing was to be done.There was no reported patient injury.

• 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: 8189662
• MDR Text Key: 131302214
• Report Number: 3006260740-2018-03697
• 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: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• 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: 12/27/2018
• Event Location: Hospital
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1