MAUDE Adverse Event Report: BARD ACCESS SYSTEMS PICC; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number UNKNOWN

Device Problem Torn Material (3024)

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

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 following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the report that the purple luer connector had been pulled from the extension leg was confirmed as use related.A d/l powerpicc was received without the purple luer connector.The extension leg that was missing the luer connector was tied in a knot.The printing was completely worn from the extension leg that was missing the luer connector and partially worn from the extension leg with the red connector.Both clamps were present on the extension legs.Impressions from clamping and/or kinking were observed in the damaged extension leg.What appears to be residual adhesive from a dressing was visible on the external surface of the extension legs.The damaged extension leg extended 7.7 cm from the proximal end of the bifurcation, which indicates that the tubing broke within the hub.The d/l tubing extended 39.2 cm from the distal end of the bifurcation.A microscopic examination of the proximal end of the damaged extension leg revealed that the cross section was rough and jagged around a portion of the perimeter, which is indicative of a break or tear in the material.A functional test revealed that both lumens were patent to infusion and no leaks were observed.Due to the condition of the catheter, it appears that the tear in the extension leg tubing occurred during use.Potential contributors to the damage include excessive stress in the material from pulling, twisting, bending, and or clamping near the luer connector.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Per sales representative, facility reported that the hub had been pulled off the lumen.He stated that the lumen looked torn, but that the picc was okay, it was still under the dressing.He stated that it also looked like the lumen had been clamped.No patient harm reported.

• Brand Name: PICC
• 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: 6372337
• MDR Text Key: 69209801
• Report Number: 3006260740-2017-00174
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2017
• 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: 02/13/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 02/13/2017
• 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