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

Model Number	CK000754
Health Effect - Clinical Code	No Information (3190)
Date of Event	12/14/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: 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: 7311629
• Report Number: 3006260740-2018-00359
• Device Sequence Number: 1368411
• Product Code: LJS
• UDI-Device Identifier: 00801741141584
• UDI-Public: (01)00801741141584
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: CK000754
• Device Catalogue Number: CK000754
• Device Lot Number: 17HB5026
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention