MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE PROBE COVER KIT WITH GEL (48 IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number	N/A
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of redq0766 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that once the cover was fitted upon the probe of the ultrasound, it was noted a hole in the probe where the gel was leaking out.
Additional 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 probe cover holes was confirmed but the exact cause is unknown.One probe cover was returned with a drape in open packaging.The packaging label information showed lot: redq0766.Acoustic gel was present within the probe cover.A tear was observed 0.7 cm from the distal end of the cover.The tear was longitudinal and 2 cm in length.Microscopic observation of the tear revealed the edges to be uneven with points of material elongation.Based on the condition of the sample returned, possible contributing factors include damage during assembly of the device and excessive force applied during use.The product instructions for use (ifu) states, "caution: always snap the needle guide on to the probe hook.Do not slide the needle guide on to the needle guide hook, as the sterile sheath may tear." a lot history review (lhr) of redq0766 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that once the cover was fitted upon the probe of the ultrasound, it was noted a hole in the probe where the gel was leaking out.

• Brand Name: SITE~RITE PROBE COVER KIT WITH GEL (48 IN)
• Common Device Name: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9179747
• Report Number: 3006260740-2019-02966
• Device Sequence Number: 2591576
• Product Code: ITX
• UDI-Device Identifier: 00801741037801
• UDI-Public: (01)00801741037801
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2019

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
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 9001C0197
• Device Lot Number: REDQ0766
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Event Location: Home
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 10/11/2019
• Supplement Report FDA Received Date: 11/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Weight: 70