MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE ST MAX BARRIER KIT; MIDLINE CATHETER

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2019

Event Type  malfunction  

Manufacturer Narrative

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 complaint of a hair in the powerglide tray was confirmed; however, the root cause was not identified.The product returned for evaluation was one photograph depicting a portion of max barrier kit.The depicted portion included a saline syringe, lidocaine ampoule and portions of folded drape.The components rested on the unfolded outer wrapping.A hair-like fiber was observed on the wrap.While a hair was evident in the submitted photograph, the opened state of the packaging prevented determination of when the hair was deposited.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.Potential contributing factors include hair deposition during kit assembly and following kit opening.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 a hair was lodged underneath the sterile drape of a powerglide st max barrier kit.It was stated the nurse was sure it was not her hair as her cap was already on.

• Brand Name: POWERGLIDE ST MAX BARRIER KIT
• Type of Device: MIDLINE 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: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 9371792
• MDR Text Key: 167885486
• Report Number: 3006260740-2019-03682
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2019
• 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: 11/08/2019
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 11/06/2019
• 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