MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; PERCUTANEOUS, IMPLANTED, LONG TERM INTRAVASCULAR CATHETER

Catalog Number 7726950

Device Problems Hole In Material (1293); Leak/Splash (1354)

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

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rear1149 showed one other similar product complaint(s) from this lot number.Device not yet returned for evaluation.

Event Description

On (b)(6) 2016 - per sales representative, facility reported that after a catheter was placed, it began to leak.The leak was noticed near the cuff when the catheter was flushed with saline.The staff examined the catheter and found a hole.A new device was placed and no harm to the patient was reported.

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, 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 a leaking central venous catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 9.5fr d/l groshong central venous catheter.The investigation findings are consistent with catheter damage caused by contact with a sharp edged instrument such as a scalpel.The returned product sample was evaluated and a split was observed just proximal of the tissue ingrowth cuff.Microscopic examination of the catheter split confirmed it was typical of contact with a sharp bladed instrument, and the characteristics observed which supported this type of failure included: ¿ the fracture surface was reflective in nature and contained a striated pattern.This can occur due to pattern transfer of the sharpened edge typically found on a scalpel-type instrument.¿ sharply formed fracture edges ¿ planar shape to the fracture surface.The short time frame between the insertion date and the date of discovery suggests this damage likely occurred during insertion.An examination of the catheter structure revealed no potential damage/defect related to manufacture of the product.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• 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: maren treft ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225964
• MDR Report Key: 5848568
• MDR Text Key: 52401830
• Report Number: 3006260740-2016-00390
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570(17)210428(10)REAR1149
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K860256
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2021
• Device Catalogue Number: 7726950
• Device Lot Number: REAR1149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 08/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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