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

Model Number N/A

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 07/30/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of redq2657 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 is confirmed but the exact cause remains unknown.One plastic probe cover was returned for evaluation.Evidence of use and gel was present.Water was poured into the bag to identify any leaks or tears in the plastic.A leak was observed near the distal end of the bag approximately 1.5 cm from the sealed section.Microscopic observation of the leak location revealed a triangular shaped tear.The edges of the tear were observed to be rough and uneven.The plastic near the triangular point was observed be stretched.The uneven and stretched plastic on the tear edge suggest blunt, pointed object was pressed into the cover leading to the tear.The source of the damage remains unknown and may have occurred during use of the device.A review of the manufacturing records did not revealed any evidence to suggest a manufacturing related root cause contributed to the reported event.Since the probe cover was observed to be damaged, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of redq2657 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.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G) (POLYETHYLENE) (48IN)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• MDR Report Key: 10434593
• MDR Text Key: 204352691
• Report Number: 3006260740-2020-02991
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REDQ2657
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 07/30/2020
• Initial Date FDA Received: 08/20/2020
• Supplement Dates Manufacturer Received: 09/29/2020
• Supplement Dates FDA Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2019
• 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