MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of recv1660 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported that during use of the catheter the nurse felt resistance and instinctively pulled back on it after it was deployed which caused the catheter to shear, the guidewire became bent.Patient experienced trauma but no major harm mentioned.On 12/4/18 - additional information received stated, "there was no cut down, snare, surgical removal necessary to remove the device.The clinician felt resistance as she was advancing the catheter after guidewire was successfully deploy.Her instinct was to remove the entire device but in doing so sheared the catheter.It was during removal that the tip of the guidewire was held up on the patient¿s tissue.".
Event or Problem Description
It was reported that during use of the catheter the nurse felt resistance and instinctively pulled back on it after it was deployed which caused the catheter to shear, the guidewire became bent.Patient experienced trauma but no major harm mentioned.On 12/4/18 additional information received stated, "there was no cut down, snare, surgical removal necessary to remove the device.The clinician felt resistance as she was advancing the catheter after guidewire was successfully deploy.Her instinct was to remove the entire device but in doing so sheared the catheter.It was during removal that the tip of the guidewire was held up on the patient¿s tissue.".
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 sheared catheter is confirmed and appears to be related to the use of the device.One 20 ga powerglide pro device was returned for investigation.Use residue was observed.The catheter was observed to be sheared 2.2 cm from the distal end.The needle was observed to be protruding from the split in the catheter.The guidewire was observed to be intact at the location of the split in the catheter.A product label sticker was returned with ref: (b)(4) and lot: recv1660.Based on the position of the catheter and split location relative to the needle, it is likely that the catheter was sheared due to retraction against the needle bevel.The product ifu warns, ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿ a lot history review (lhr) of recv1660 showed no other similar product complaint(s) from this lot number.

• Brand Name: FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
• 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: 8164549
• Report Number: 3006260740-2018-03593
• Device Sequence Number: 11114218
• Product Code: FOZ
• UDI-Device Identifier: 00801741140679
• UDI-Public: (01)00801741140679
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K162377
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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 Expiration Date: 11/30/2019
• Device Model Number: N/A
• Device Catalogue Number: F320088PT
• Device Lot Number: RECV1660
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/19/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 12/14/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1