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U.S. Department of Health and Human Services

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

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BARD ACCESS SYSTEMS SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN) TRANSDUCER, ULTRASONIC, DIAGNOSTIC Back to Search Results
Model Number N/A
Device Problem Defective Component (2292)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/07/2020
Event Type  malfunction  
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 defective needle guide is inconclusive due to the condition the sample was returned in. One 18g needle guide kit was returned for evaluation. An initial visual observation showed the kit was returned open, and all of the kit components were found within the open kit. A short light yellow-brown hair was observed on one corner of the csr wrap within the open kit. The needle guides were found to be positioned within the card correctly. No damage was observed on any of the returned samples or the packaging. No damage or defect was found on any of the returned samples. A hair was found on the csr wrap within the open package; however, it was not possible to determine when or where the hair came into contact with the csr wrap as the kit was returned open. A lot history review (lhr) of redx4812 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that "we recently had a defective needle guide kit during a procedure. " on (b)(6) 2020: kit was used on patient, but no harm reported. On (b)(6) 2020 - a needle guide kit was returned for evaluation. Although, the needle guides themselves were intact and without damage, a hair was found on the csr wrap. This file will be conservatively reported for foreign material in the package.
 
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Brand NameSITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN)
Type of DeviceTRANSDUCER, ULTRASONIC, DIAGNOSTIC
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 Key9953766
MDR Text Key195752131
Report Number3006260740-2020-01242
Device Sequence Number1
Product Code ITX
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K042445
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/13/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/13/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number9001C0212
Device Lot NumberREDX4812
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/24/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/27/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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