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

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.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (18G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, 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 Key: 9953766
• Report Number: 3006260740-2020-01242
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037818
• UDI-Public: (01)00801741037818
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: N/A
• Device Catalogue Number: 9001C0212
• Device Lot Number: REDX4812
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020

Is the Reporter a Health Professional?

Was the Report Sent to FDA?

• Event Location: Hospital
• Date Manufacturer Received: 03/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial