MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PPICC 5F DL RN; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number CK000754

Device Problem Knotted (1340)

Patient Problem No Information (3190)

Event Date 12/14/2017

Event Type  Injury  

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) of 17hb5026 showed one other similar product complaint(s) from this lot number.- [mw5074514.Device has not yet been returned for evaluation.

Event Description

It was reported that a knotted picc line was discovered during an operation to correct an alleged "looped malposition." when the knotted catheter was discovered the procedure was aborted and the picc was removed from the patient's upper extremity.

• Brand Name: DOT PPICC 5F DL RN
• 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): MEDLINE INDUSTRIES; 11 norfolk st; mansfield MA 02048
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7311629
• MDR Text Key: 101464897
• Report Number: 3006260740-2018-00359
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741141584
• UDI-Public: (01)00801741141584
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CK000754
• Device Catalogue Number: CK000754
• Device Lot Number: 17HB5026
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• 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