MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SHERLOCK 3CG+ DISPLAY; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number 9770351

Device Problems Retraction Problem (1536); Data Problem (3196)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per tm: initial cxr report read as 2 cm too long.The picc was retracted 2 cm.Repeat cxr report read as acceptable.3cg+ image shows no negative deflection.

Manufacturer Narrative

The information provided by bd 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 bd.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: product was not returned for evaluation/repair.Photo samples of the ecg tracings and chest x-rays were provided.Radiologist review of the chest x-rays confirmed the initial picc placement was longer than the expected position and tip could be in the right atrium.Furthermore, review of the second chest x-ray confirmed picc was retracted 2 cm and was located at an acceptable location.Radiologist review also noted the difference between the first and second chest x-ray could be related to inspiratory (initial x-ray) versus expiratory (second x-ray) state of the patient, possibly causing the picc placement to appear deep when in actuality it may have been on the upper cusp of normal placement.Complaint investigation and root cause determination could not be completed without physical evaluation of the unit.A history review of serial number (b)(4) showed no other similar complaint(s) from this serial number.

Event Description

Per tm: initial cxr report read as 2cm too long.The picc was retracted 2cm.Repeat cxr report read as acceptable.3cg+ image shows no negative deflection.

• Brand Name: SHERLOCK 3CG+ DISPLAY
• Type of Device: CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8505333
• MDR Text Key: 142044772
• Report Number: 3006260740-2019-00855
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• PMA/PMN Number: K180560
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 11/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 9770351
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2019
• Event Location: Hospital
• Date Manufacturer Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 YR