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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G)(48IN) TRANSDUCER, ULTRASONIC, DIAGNOSTIC

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C.R. BARD, INC. (BASD) -3006260740 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G)(48IN) TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
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.
 
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Brand NameSITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G)(48IN)
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11065710
MDR Text Key224326244
Report Number3006260740-2020-21065
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
PMA/PMN Number
K042445
Number of Events Reported1
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 Received12/23/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number9001C0212
Device Lot NumberRECZ0495
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2020
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/15/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/23/2020 Patient Sequence Number: 1
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