MAUDE Adverse Event Report: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G)(48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Catalog Number 9001C0212

Device Problems Break (1069); Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/15/2020

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged probe cover was confirmed but the exact cause remains unknown.One opened siterite kit packaging and one probe cover were returned for investigation.The product information on kit label indicated lot: recz0495.Gel was present within the probe cover.Inspection of the probe cover revealed a tear 3.2 cm from the distal end and 2 cm from the edge.Microscopic observation of the damaged region revealed the tear edges to be stretched and uneven.The stretched portions of the tear were also observed to be radiating outwards.The characteristics of the tear suggest an object was likely pressed against the probe cover leading to the tear.This can occur if the needle guide damages the probe cover during attachment.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the damage was present on the probe cover, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of recz0495 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that the probe cover found to be damaged as some gel came out from inside of probe cover.There was no reported patient involvement.

Manufacturer Narrative

H11: section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history, applicable previous investigation(s), labeling, applicable manufacturing records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged probe cover was confirmed but the exact cause remains unknown.One opened siterite kit packaging and one probe cover were returned for investigation.The product information on kit label indicated lot: recz0495.Gel was present within the probe cover.Inspection of the probe cover revealed a tear 3.2 cm from the distal end and 2 cm from the edge.Microscopic observation of the damaged region revealed the tear edges to be stretched and uneven.The stretched portions of the tear were also observed to be radiating outwards.The characteristics of the tear suggest an object was likely pressed against the probe cover leading to the tear.This can occur if the needle guide damages the probe cover during attachment.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the damage was present on the probe cover, the complaint is confirmed but the exact cause remains unknown.H3 other text : evaluation findings are in section h.11.

Event Description

It was reported that the probe cover found to be damaged as some gel came out from inside of probe cover.There was no reported patient involvement.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G)(48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 11065710
• MDR Text Key: 224326244
• Report Number: 3006260740-2020-21065
• Device Sequence Number: 1
• Product Code: ITX
• Combination Product (y/n): N
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9001C0212
• Device Lot Number: RECZ0495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Date Manufacturer Received: 01/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2018
• 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 Outcome(s): Other