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

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
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 redq0594 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that once inserted the cover upon the probe of the ultrasound, the cover opened causing loss of sterility.It appears a longitudinal hole in the bag following the welding of the plastic.
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 a broken probe cover confirmed and appeared to be related to the use of the device.Two siterite probe cover kits were returned for investigation in opened packaging.This report addresses the first sample.The product label showed lot: redq0594.The probe cover was removed from the packaging.Evidence of use was observed as gel was present throughout the sample.The first bag was filled with water to determine the leak locations.Two leaks were observed.One was located at the distal end of the bag near the center of the seam.The second leak was located approximately 5 cm from the distal end.Based on the characteristics of the damage observed on both probe covers, the damage was likely caused during handling and use of the device.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.".
Event or Problem Description
It was reported that once inserted the cover upon the probe of the ultrasound, the cover opened causing loss of sterility.It appears a longitudinal hole in the bag following the welding of the plastic.Two probe covers were returned.This report addresses the first probe cover.

• 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: 8917677
• Report Number: 3006260740-2019-02441
• Device Sequence Number: 2206283
• 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): 09/12/2019

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: REDQ0594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/21/2019
• Supplement Report FDA Received Date: 09/12/2019
• 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: 65