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 7711804

Device Problem Material Integrity Problem (2978)

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

Event Date 10/13/2017

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 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.An 8 fr groshong single-lumen catheter was returned for investigation.The catheter was received with the stylet in the lumen.The cuff was received separate from the catheter.Dry blood residue was observed throughout the cuff fibers.Adhesive residue remained where the cuff had been positioned.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 24 and 25 cm depth marks, which indicates that the catheter was stretched in the area of the cuff.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 rebp0596 showed no other similar product complaint(s) from this lot number.

Event Description

During evaluation by the engineer it was discovered that the cuff had come off the catheter.No reported patient injury.

• Brand Name: GROSHONG 8F SINGLE-LUMEN CV CATHETER PEEL-APART INTRODUCER KIT WITH SURECUFF
• 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 REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7153399
• MDR Text Key: 96030101
• Report Number: 3006260740-2017-02323
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741036767
• UDI-Public: (01)00801741036767
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K831386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2017

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
• Device Operator: Health Professional
• Device Model Number: 7711804
• Device Catalogue Number: 7711804
• Device Lot Number: REBP0596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/09/2017
• Initial Date FDA Received: 12/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2017
• 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