MAUDE Adverse Event Report: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of redn1190 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there are black spots on the guide rack of 1.0 needle, which seems to have gone moldy.

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 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 black spots of the needle guide is confirmed but the exact cause remains unknown.One photo sample of a ultrasound probe, probe cover, and needle guide accessory was provided for evaluation.The ultrasound probe and accessory components are shown in use.The green needle guide is shown to have two dark, discolored regions.The cause or source of the discoloration cannot be clearly discerned from the photo provided.The condition of packaging is also unknown.Since the discoloration was observed, the complaint is confirmed; however, the photos did not allow for the determination of a specific root cause.A lot history review (lhr) of redn1190 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there are black spots on the guide rack of 1.0 needle, which seems to have gone moldy.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10217544
• MDR Text Key: 197747176
• Report Number: 3006260740-2020-02298
• 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: company representative
• Type of Report: Initial,Followup
• Report Date: 07/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REDN1190
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Event Location: Hospital
• Date Manufacturer Received: 07/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2019
• 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