MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE PROBE COVER KIT WITH GEL (48 IN); ULTRASOUND TRANSDUCER AND ACCESSORIES

Model Number	N/A
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The information provided by bard 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 bard.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reax1853 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that on (b)(6) 2017 the probe cover kit with gel was opened for the procedure.A black hair was identified inside the probe cover.The product was not used on the patient.
Additional Manufacturer Narrative
The initial report was marked as a 30-day and 5-day report.The correct report type is 30-day.The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records.Based on a review of this information, the following was concluded: the complaint of a hair in the prove cover was inconclusive due to the sample condition.One probe cover was received in an open pouch.The probe cover was the only item returned in the package.The cover was neatly folded and showed no indication of being modified from the manufactured state.No hair was observed in the probe cover or in the open pouch.Static electricity have deflected the hair from the probe cover and/or packaging at any location between the complainant facility and bard.Whether the hair was inadvertently introduced during handling and packaging or after opening cannot be verified.A review of the device history record (dhr) showed no deviations/issues associated with this problem in regards to product materials, manufacturing, or qc inspection processes.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot.
Event or Problem Description
It was reported that on (b)(6) 2017 the probe cover kit with gel was opened for the procedure.A black hair was identified inside the probe cover.The product was not used on the patient.

• Brand Name: SITE~RITE PROBE COVER KIT WITH GEL (48 IN)
• Common Device Name: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6745393
• Report Number: 3006260740-2017-01129
• Device Sequence Number: 1372241
• Product Code: ITX
• UDI-Device Identifier: 00801741037801
• UDI-Public: (01)00801741037801
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: N/A
• Device Catalogue Number: 9001C0197
• Device Lot Number: REAX1853
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 07/26/2017
• Supplement Report FDA Received Date: 08/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1