MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SR 8 WITH PINPOINT GT; ULTRASONIC PULSED ECHO IMAGING SYSTEM

Catalog Number 9770501

Device Problems Improper or Incorrect Procedure or Method (2017); Malposition of Device (2616)

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

Event Type  malfunction  

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

On 10/14/2016 - facility reported: at the time of placement, healthcare professional achieved max p wave and was confident that the picc was in the correct position (the depth marking on the picc was at 0cm).A confirmation chest x-ray at the time of placement was not done.Two weeks later, a chest x-ray was taken and incidentally found that the picc was in the right atrium.The physician pulled the picc back 6cm and another chest x-ray confirmed that the picc was now in the correct position at the caj.Facility reported that during initial placement, the nurse was confident that she was in the correct place but now it seems that she was 6cm too deep.

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 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 malpositioned picc was inconclusive as the exact circumstances in the clinical setting were unknown and no potential cause was discovered during evaluation of the returned equipment.Evaluation of the unit was performed by the service facility, (b)(4).The scanner was evaluated by the service facility with an in-house sherlock and ecg simulator and the scanner was found to function normally.After manufacturing review of dhr and manufacturing records, there is no evidence that would support the event being a manufacturer-related failure.The reported issue could not be reproduced and the root cause is inconclusive as they could not duplicate the clinical setting.

Event Description

On 10/14/2016 - facility reported: at the time of placement, healthcare professional achieved max p wave and was confident that the picc was in the correct position (the depth marking on the picc was at 0cm).A confirmation chest x-ray at the time of placement was not done.Two weeks later, a chest x-ray was taken and incidentally found that the picc was in the right atrium.The physician pulled the picc back 6cm and another chest x-ray confirmed that the picc was now in the correct position at the caj.Facility reported that during initial placement, the nurse was confident that she was in the correct place but now it seems that she was 6cm too deep.Additional information from facility stated: the external catheter measurement was at 49cm marking.The patient's rhythm during insertion was a-fib but clear p wave elevation with internal ecg insertion.The facility stated the negative deflection was noted when catheter hubbed.I like to see the deflection, especially on a-fib patients.The line was retracted back to 0cm.It was reported that the facility does not rely on 3cg with a-fib unless they can clearly see the p wave elevation.

• Brand Name: SR 8 WITH PINPOINT GT
• Type of Device: ULTRASONIC PULSED ECHO IMAGING SYSTEM
• 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: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 6080674
• MDR Text Key: 59558257
• Report Number: 3006260740-2016-00582
• Device Sequence Number: 1
• Product Code: IYO
• UDI-Device Identifier: 00801741124341
• UDI-Public: (01)00801741124341
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152554
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 05/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770501
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 04/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1