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 Defective Component (2292)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reds0103 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the gel was put on the ultrasound transducer and when the sterile cover was put on, the gel came through tiny holes on the top of the cover.

Event Description

It was reported that the gel was put on the ultrasound transducer and when the sterile cover was put on, the gel came through tiny holes on the top of the cover.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), labeling, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of holes in a probe cover is unconfirmed as the alleged problem could not be reproduced.Eighty-two sealed 21 g site rite needle guide kits were returned for evaluation.An initial visual observation showed each kit was returned sealed.Each kit was opened and the distal end of each probe cover was examined.No holes or tears were observed in any of the returned samples.The distal end of some of the probe cover samples were filled with water and no leaks were observed in any of these samples.A microscopic observation revealed no holes or tears in any of the returned samples.A lot history review (lhr) of reds0103 showed no other similar product complaint(s) from this lot number.

• 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: 9225531
• MDR Text Key: 163544858
• Report Number: 3006260740-2019-03299
• 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: distributor
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

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: REDS0103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2019
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/02/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 11/19/2019
• Supplement Dates FDA Received: 11/27/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1