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

Model Number N/A

Device Problems Leak/Splash (1354); 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 manufacturer has received the sample and will evaluate.Results are expected soon.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 hub of the powerpicc was torn and leaking, more specifically at the top of the catheter, beneath the hub.No patient injury was reported.

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 leaking and torn extension tubing was confirmed and an internal investigation will document the ongoing investigation of this type of event.The product returned for evaluation was a 3fr powerpicc provena catheter.The sampled contained red usage residue throughout and white/gray dressing residue on the extension leg and molded joint.Gross visual evaluation confirmed the presence of a circumferential split in the extension tubing underneath the luer connector, at the interface of the distal connector edge and extension tubing.Microscopic examination of the damage showed that the fracture surface was rough and granular and the damage regions correlated to points where the extension tube appeared to be irregularly adhered to the luer hub.No damage existed in regions of the extension tube which were not tacked to the luer hub.Examination of the fracture surface found striation-like lines which are typical of fatigue based failures.The fracture features at the damage site appeared similar to fatigue damage and flexural fatigue may have been a contributing factor but the damage location and tacking of the extension tube to the luer wall suggest other, unknown, contributing factor(s) may have also been involved.An internal investigation is currently ongoing to determine the root cause of events similar to this; reference 3006260740-12-21-2017-001-c (z#-tbd) 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 hub of the powerpicc was torn and leaking, more specifically at the top of the catheter, beneath the hub.No patient injury was reported.

• Brand Name: BARD POWERPICC
• 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7319575
• MDR Text Key: 101857680
• Report Number: 3006260740-2018-00384
• 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: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2018
• 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: 03/02/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 03/09/2018
• 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
• Patient Age: 11 YR