MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SL POWERPICC SOLO CATHETER BASIC WITH TLS; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	9194118
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/26/2017
Type of Reportable Event	Malfunction
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 reaz1437 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the picc line was found to be allegedly kinked in left arm and was removed.Originally inserted to upper svc, occlusion not resolved with tpa.Cxr showed line 10cm shorter but no additional length on skin.Obvious kink when removed.Infused ct previous day.It was noted that this has occurred in the past numerous times in late 2015 and early 2016.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 kinked catheter was confirmed and the cause appeared to be use-related.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Light usage residues were observed throughout the sample.The catheter terminated between the 46cm and 47cm depth markings.A permanent kink impression was observed between the 9cm and 10cm depth markings.The sample kinked preferentially at the kink impression site during manual manipulation.Microscopic inspection of the sample confirmed the presence of a permanent partially circumferential impression at the kink site.Material buckling was observed in the vicinity of the kink.The catheter buckling and permanent kink impression appeared to be the result of sample manipulation.The usage residue suggested that manipulation occurred during device use.The product nursing guide states ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿.
Event or Problem Description
It was reported that the picc line was found to be allegedly kinked in left arm and was removed.Originally inserted to upper svc, occlusion not resolved with tpa.Cxr showed line 10cm shorter but no additional length on skin.Obvious kink when removed.Infused ct previous day.It was noted that this has occurred in the past numerous times in late 2015 and early 2016.No patient injury was reported.

• Brand Name: 4 FR SL POWERPICC SOLO CATHETER BASIC WITH TLS
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6585332
• Report Number: 3006260740-2017-00676
• Device Sequence Number: 979620
• Product Code: LJS
• UDI-Device Identifier: 00801741028618
• UDI-Public: (01)00801741028618(17)180630(10)REAZ1437
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 9194118
• Device Catalogue Number: 9194118
• Device Lot Number: REAZ1437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 07/18/2017
• Initial Report FDA Received Date: 05/23/2017
• Supplement Report FDA Received Date: 07/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1