MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UNKNOWN CHRONIC CATHETER; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS

Catalog Number UNK CHRONIC CATHETER

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Hematoma (1884); Unspecified Infection (1930); Pneumothorax (2012)

Event Type  Injury  

Manufacturer Narrative

As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Journal article citation: bosch, c.H.V.D., bruggen, j.T.V.D., frakking, f.N., scheltinga, c.E.T.V., ven, c.P.V.D., grotel, m.V., wijnen, m.H.(2019).Incidence, severity and outcome of central line related complications in pediatric oncology patients; a single center study.Journal of pediatric surgery, 54(9), 1894¿1900.Doi: 10.1016/j.Jpedsurg.2018.10.054.(b)(4).

Event Description

It was reported in an article from the journal of pediatric surgery titled " incidence, severity and outcome of central line related complications in pediatric oncology patients; a single center study " that pneumothorax was identified in 1 patient, other surgical complications was identified in 11 patients, which required device removal in 1 patient, hematoma was identified in 12 patients, central line-associated blood stream infections(clabsis) were identified in 64 patients, which required device removal in 34 patients, local infection was identified in 27 patients, which required device removal in 4 patients, and thrombosis was identified in 5 patients, which required device removal in 2 patients.All patients with infection were treated with systemic antibiotic therapy (sat).The status of the patients was not provided.

• Brand Name: UNKNOWN CHRONIC CATHETER
• 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
• Manufacturer (Section G): BARD SHANNON LIMITED; san geronimo industrial park; lot #1, road #3, km 79.7; humacao 00791
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9406172
• MDR Text Key: 169056966
• Report Number: 3006260740-2019-03733
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK CHRONIC CATHETER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/12/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention