MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	7711700
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/01/2018
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 rebq1598 showed one other similar product complaints from this lot number.
Event or Problem Description
Facility reported to the sales rep that the cuff on the catheter was not secure and was "moving".A new device was used to complete the procedure.No patient injury 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 detached catheter cuff was confirmed and the cause was determined to be use related.The product returned for evaluation was a 7fr groshong chronic central catheter.The sampled contained usage residue throughout the length of the tubing and the cuff was completely discolored a red/brown color.Gross visual evaluation of the device confirmed that the cuff was completely detached from the catheter and could be slid along the catheter tubing.Microscopic examination of the cuff adhesive residue on the catheter found that the adhesive had been appropriately applied.Tactile evaluation revealed extreme tensile strength loss between the 24cm-27cm depth markings (immediately proximal of the originally-adhered cuff).Extreme tensile strength loss was also observed at the proximal end of the catheter.The observed strength loss, along with no apparent evidence of a manufacture anomaly, was indicative of a tensile event which caused the cuff to become detached from the catheter, likely during use.A lot history review (lhr) of rebq1598 showed one other similar product complaints from this lot number.
Event or Problem Description
Facility reported to the sales rep that the cuff on the catheter was not secure and was "moving".A new device was used to complete the procedure.No patient injury reported.

• Brand Name: GROSHONG 7F SINGLE-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF INTERMED
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7304410
• Report Number: 3006260740-2018-00314
• Device Sequence Number: 19151546
• Product Code: LJS
• UDI-Device Identifier: 00801741036736
• UDI-Public: (01)00801741036736
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K831386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2018

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 Model Number: 7711700
• Device Catalogue Number: 7711700
• Device Lot Number: REBQ1598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 03/06/2018
• Initial Report FDA Received Date: 02/28/2018
• Supplement Report FDA Received Date: 04/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1