MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN CATHETER 45 CM OVERALL L; LONG TERM INTRAVASCULAR CATHETER

Model Number	0600450
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	06/29/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rezb1516 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
Reported extravasation of serum therapy, via insertion of catheter.After bone marrow transplant, patient received continuous serum therapy.Healthcare professional alleges cleft in catheter.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 breach in the catheter was inconclusive based on the evidence provided for investigation.Two radiographic images were provided for investigation.At this time, no physical sample was provided by the complainant.The images showed the thoracic region.What appears to be a catheter is located on the left side of the image.An ¿r¿, designating the right side of the patient, is positioned over the left side of the image.The white shaft, assumed to be the catheter, exhibits variable thickness and appears thicker near the center of the thoracic region.While what appears to be variable catheter thickness could be attributable to a breach in the catheter, the complaint could not be verified with the radiographic images.Without the physical sample or a photograph of a breach in the tubing, the complaint of a device related defect or damage could not be confirmed; therefore, the complaint is inconclusive.
Event or Problem Description
Reported extravasation of serum therapy, via insertion of catheter.After bone marrow transplant, patient received continuous serum therapy.Healthcare professional alleges cleft in catheter.No patient injury was reported.
Additional Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency 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 breach in the catheter and subsequent extravasation was unconfirmed since the reported event could not be reproduced.Two radiographic images were provided for investigation.The lighter colored shaft in the images, assumed to be the catheter, exhibits variable thickness and appears thicker near the center of the thoracic region.The physical sample was also returned for investigation and evidence of use was observed on the catheter.A suture was tied around the catheter between the bifurcation and the cuff.Residue was observed within the fibers of the cuff.No damage was observed on the catheter.A functional test revealed that the lumens were patent to infusion, but no breaches or leaks were observed in the catheter.The reported event could be attributable to a fibrin sheath, but no damage or defects were observed on the returned catheter.
Event or Problem Description
Reported extravasation of serum therapy, via insertion of catheter.After bone marrow transplant, patient received continuous serum therapy.Healthcare professional alleges cleft in catheter.No patient injury was reported.

• Brand Name: HICKMAN HEMODIALYSIS/APHERESIS 13.5 FR ROUND DUAL-LUMEN CATHETER 45 CM OVERALL L
• Common Device Name: LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6786180
• Report Number: 3006260740-2017-01278
• Device Sequence Number: 19092463
• Product Code: LJS
• UDI-Device Identifier: 00801741037443
• UDI-Public: (01)00801741037443
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K830233
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2017

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: Other
• Device Expiration Date: 02/28/2020
• Device Model Number: 0600450
• Device Catalogue Number: 0600450
• Device Lot Number: REZB1516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 07/21/2107
• Supplement Date Received by Manufacturer: 08/14/2017; 09/11/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 08/29/2017; 11/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Weight: 68