MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number 0600570

Device Problems Backflow (1064); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/07/2017

Event Type  malfunction  

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 huau0365 showed no other similar product complaint(s) from this lot number.

Event Description

The facility reported that the rn referenced white lumen weakness noted in reinforced part of lumen with blood backing into clave.It was stated the weakness was noted in the inner layers.The line was repaired with no harm to the patient.No patient injury was reported.

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 lumen weakness was confirmed and the cause appeared to be use-related.The product returned for evaluation was one white-luered hickman stylet extension tube.The sample terminated approximately 1cm distal of the clamping over-sleeve.The extension tubing markings were completely worn.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion; however, ballooning of the catheter was observed in the catheter tubing just distal of the crimp collar.Tactile inspection of the sample revealed severe tensile weakness near the crimp collar.Clamping impressions were observed throughout the over-sleeve, including near the crimp collar.The translucence of the sample in the vicinity of the tensile weakness and ballooning suggested that the internal lumen was partially or fully split.The tensile weakness, ballooning and inner lumen split were consistent with damage caused by clamping the catheter adjacent to the crimp collar, outside of the ¿clamp here¿ region.The product ifu states ¿always clamp the catheter over the reinforced clamping sleeve or tape tab, as instructed by your nurse.Never clamp over the reinforced segment directly adjacent to the connector.¿.

Event Description

The facility reported that the rn referenced white lumen weakness noted in reinforced part of lumen with blood backing into clave.It was stated the weakness was noted in the inner layers.The line was repaired with no harm to the patient.No patient injury was reported.

• Brand Name: HICKMAN 7 FR DUAL-LUMEN CV CATHETER, PEEL-APART INTRODUCER KIT WITH SURECUFF TI
• Type of Device: PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6682423
• MDR Text Key: 79123627
• Report Number: 3006260740-2017-00962
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741051869
• UDI-Public: (01)00801741051869(17)210728(10)HUAU0365
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K830233
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/04/2017

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
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 0600570
• Device Catalogue Number: 0600570
• Device Lot Number: HUAU0365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2017
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/30/2017
• Supplement Dates Manufacturer Received: 06/29/2017
• Supplement Dates FDA Received: 08/04/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2016
• 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