MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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 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 that the cuff detached from the catheter was confirmed, and the cause appears to be use related.It was reported that the loose cuff was observed ¿during prepping¿.An 8 fr groshong single-lumen catheter was returned for investigation.The catheter was received without the stylet.The overall length of the catheter was 49.5cm.The surecuff was received loose over the catheter tubing and was positioned between the 19 and 20 cm depth marks.Blood residue was observed along the length of the catheter and within the fibers of the cuff.A microscopic examination of the cuff revealed nothing remarkable.Adhesive remained attached to the catheter at the 24cm depth mark.The cuff weave pattern was visible in the adhesive that remained on the catheter, which indicates that the cuff had been adhered to the tubing.A tactual investigation revealed elastic weakness in the 8 fr tubing between the 23 and 27 cm depth marks, which indicates that the catheter was stretched in the area of the cuff.Greater weakness was detected in the section of tubing between the 24 and 27 cm depth marks than what was observed between the 23 and 24 cm depth marks a functional test revealed that the catheter was patent to infusion and no leaks were observed.The ifu indicates to not use the catheter if there is any evidence of mechanical damage.The condition of the returned sample indicates that the product was used.The ifu cautions that the catheter must not be forced during tunneling.The ifu states, ¿gently holding the catheter distal to the cuff while pulling the tunneler and catheter through subcutaneous tunnel should result in smooth passage of the cuff(s) through the subcutaneous tunnel.¿ a lot history review (lhr) of reaw0771 showed (b)(4) other similar product complaint(s) from this lot number.
Event or Problem Description
Per sales representative, the facility reported that during prepping of the catheter, the tech noticed that the tissue ingrowth cuff was not adhered to the catheter and could move freely up and down.The catheter was isolated and a second kit was opened and used on the patient.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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: 6461552
• Report Number: 3006260740-2017-00354
• Device Sequence Number: 10914049
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767(17)210930(10)REAW0771
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 04/05/2017

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: 09/30/2021
• Device Model Number: N/A
• Device Catalogue Number: 7711804
• Device Lot Number: REAW0771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2017
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/23/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1