MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SITE~RITE 6 PROBE; SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC

Catalog Number 9770001

Device Problem Electrical /Electronic Property Problem (1198)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as the device is manufactured using a unique serial number and not by lot number.A history review of serial number 12075101 showed no other similar product complaint(s) from this serial number.

Event Description

Customer reported sr6 probe has exposed wires.

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, 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: during evaluation, the reported damage cable was confirmed.Although the probe is functional, the cable was found to be damaged at the bottom of the strain relief.The damage was at the ziff end of the connector and wires were found to be exposed.There were also multiple cracks on the nose housing.The root cause of the probe damage was identified as use-related damage.The review of the dhr, sub-assembly dhr, sub-assembly manufacturing, component records, manufacturing process changes, mrr/mrb, and internal rejects showed that the reported issue is not likely related to a manufacturing issue.The probe was cleaned, tested, and determined to be not repairable.

Event Description

Customer reported sr6 probe has exposed wires.

• Brand Name: SITE~RITE 6 PROBE
• Type of Device: SYSTEM, IMAGING, PULSED ECHO, ULTRASONIC
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): DYMAX CORP. -2523003; 110 marshall drive; warrendale PA 15086
• Manufacturer Contact: kelsey erickson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225937
• MDR Report Key: 7489079
• MDR Text Key: 107587593
• Report Number: 3006260740-2018-00903
• Device Sequence Number: 1
• Product Code: IYO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071204
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 10/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770001
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/16/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 10/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1