MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	7726950
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2017
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of reax1108 showed no other similar product complaint(s) from this lot number.Device not returned yet.
Event or Problem Description
It was reported that the catheter was inserted on (b)(6) 2017.It was also reported that there was a cracking of the catheter lumen and that "the catheter contained some lactate(d) ringer." they were forced to stop the perfusion and remove the catheter the next day.
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 cracking on the catheter was confirmed and the cause was determined to be use related.The product returned for evaluation was a 9.5fr d/l groshong chronic catheter.The sample was returned with hemostats clamping the catheter near the distal tip and contained usage residue throughout.Gross visual evaluation revealed the presence of what appeared to be superficial scratch markings 1.4cm distal of the cuff.Functional testing confirmed leakage through the scratch markings when infused through the white luer only.Microscopic examination of the damage region showed that the scratch markings surrounded the entire circumference of the catheter and were of various depths.The observed damage is evidence of mechanical contact damage and it was likely that the catheter was damaged by an instrument during the insertion procedure.A lot history review (lhr) of reax1108 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that the catheter was inserted on (b)(6) 2017.It was also reported that there was a cracking of the catheter lumen and that "the catheter contained some lactate(d) ringer." they were forced to stop the perfusion and remove the catheter the next day.

• Brand Name: GROSHONG 9.5F DUAL-LUMEN CV CATHETER WITH SURECUFF TISSUE INGROWTH CUFF
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7182950
• Report Number: 3006260740-2017-02408
• Device Sequence Number: 13468685
• Product Code: FOZ
• UDI-Device Identifier: 00801741041570
• UDI-Public: (01)00801741041570
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K860256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/28/2018

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: 7726950
• Device Catalogue Number: 7726950
• Device Lot Number: REAX1108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 02/15/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 52