MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 3CG PPICC 5FR TL HF BASIC; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number	1385118Q
Health Effect - Clinical Code	Atrial Fibrillation (1729)
Date of Event	01/16/2017
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 for evaluation, as the device remains in the patient.A lot history review (lhr) of reaw1536 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reaw1536) have been reported from the same (b)(6) facility.
Event or Problem Description
Nurse reported a kink on the external portion of the picc.The picc line was inserted on (b)(6) 2017.The right cephalic vein was used, as the basilica vessel was being used for iv medication.The picc line was trimmed at 50 cm and had an external length of 1.5 cm.Chest x-ray was completed post insertion as the patient was in atrial fibrillation.Picc remains in the patient and has been secured.No patient injury reported.
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 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 5fr t/l powerpicc catheter.Usage residues were observed throughout the sample.The catheter terminated at the 50cm depth marking.Microscopic inspection of the distal tip of the sample revealed striations typical of a sharp instrument cut.The extension tubing markings and several depth markings were partially worn.A permanent kink impression was observed at the 1cm depth marking.Tactile inspection of the sample confirmed the presence of a kink impression at the 1cm depth marking.The sample kinked preferentially at the impression site during manual manipulation.Comparison between the complaint sample and a similar non-complainant device confirmed that the complaint sample kinked more easily.Microscopic inspection of the sample confirmed the presence of a permanent kink impression but was otherwise unremarkable.The preferential kinking exhibited by the complaint sample indicated that the sample had been previously kinked.The usage residues and marking wear suggested that the catheter was in use and the kink location suggested that catheter securement technique contributed to the observed event.The product ifu states ¿do not bend the catheter at sharp angles during implantation.¿.

• Brand Name: 3CG PPICC 5FR TL HF BASIC
• 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: 6321889
• Report Number: 3006260740-2017-00053
• Device Sequence Number: 579582
• Product Code: LJS
• UDI-Device Identifier: 00801741085727
• UDI-Public: (01)00801741085727(10)171130(10)REAW1536
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/28/2017

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: 11/30/2017
• Device Catalogue Number: 1385118Q
• Device Lot Number: REAW1536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Event Location: Hospital
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 03/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1