MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNK POWERGLIDE; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Catalog Number UNKNOWN

Device Problem Kinked (1339)

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), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a kinked catheter was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph which appeared to depict a portion of powerglide midline catheter.The depicted catheter exhibited curved shape memory and a sharp kink near the distal end.Possible use residue appeared to be present within the catheter.Catheter damage was evident in the depicted device; however, inspection of the supplied photograph was insufficient to identify the root cause of the damage.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.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 midline has had ¿problems ¿since the time of placement.It had to be repositioned by the staff members and eventually removed.After removal it was found that the catheter was kinked, and that the tip of the catheter seemed to have been altered, appearing ¿v-shaped.¿ there was no reported patient injury.

• Brand Name: UNK POWERGLIDE
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7469915
• MDR Text Key: 106891088
• Report Number: 3006260740-2018-00837
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2018
• 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: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/11/2018
• 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