MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 01/28/2019

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rect1220 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when opening the product for use there was a 3cm tear at the tip where the ultrasound transducer stays.The device was not used on the patient.

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 tear in the probe cover is confirmed; however, the exact cause could not be determined from the photo samples provided.Two photo samples of a siterite needle guide kit were returned for investigation.The first photo sample showed an ultrasound probe cover.Gel can be seen to be spread throughout the cover.A person with a glove is shown to have their finger through the probe cover indicating a tear is present.The second photo sample showed the outer packaging of the needle guide kit with ref: 900013b01 and lot: rect1220.Since evidence of a tear was present in the photo samples provided, the complaint is confirmed but the exact cause remains unknown.Possible contributing factors include sharp instrument damage and damage during handling.A lot history review (lhr) of rect1220 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that when opening the product for use there was a 3cm tear at the tip where the ultrasound transducer stays.The device was not used on the patient.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8364133
• MDR Text Key: 137369742
• Report Number: 3006260740-2019-00349
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771
• Combination Product (y/n): N
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 03/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 900013B01
• Device Lot Number: RECT1220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 01/29/2019
• Initial Date FDA Received: 02/22/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 03/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1