MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL; INTRAVASCULAR CATHETER

Model Number	N/A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/29/2017
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 manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of rebu2267 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that while removing the housing unit, it was noted that the catheter was bent.The device was removed and a new device used to complete the procedure.No harm to the patient other than requiring two needle sticks.
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 damaged catheter was confirmed and was determined to be related to use of the device.One 20g x 10cm powerglide catheter, which consisted of the purple hub and pink strain relief sleeve, was returned for investigation.The deployment system was not returned for investigation.A breach was observed in the catheter 1mm distal to the pink strain relief oversleeve.A microscopic examination revealed that the catheter was scored longitudinally just proximal to the circumferential breach in the tubing.Sharp edges were observed along the slit with striations on adjoining surfaces of the breach in the tubing.These characteristics at the leak site are consistent with a needle puncture.Warnings in the ifu indicate that once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.This may result in damage to the catheter.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.The ifu also indicates to not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure.Due to the evidence of use and the characteristics of the damage, the complaint was determined to be use related.A lot history review (lhr) of rebu2267 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by the facility that while removing the housing unit, it was noted that the catheter was bent.The device was removed and a new device used to complete the procedure.No harm to the patient other than requiring two needle sticks.

• Brand Name: DOT PG PRO 20G 10CM FULL
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7088162
• Report Number: 3006260740-2017-02198
• Device Sequence Number: 19061678
• Product Code: FOZ
• UDI-Device Identifier: 00801741110689
• UDI-Public: (01)00801741110689
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2018

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: N/A
• Device Catalogue Number: F220101
• Device Lot Number: REBU2267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2017
• Event Location: Hospital
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/06/2017
• Supplement Report FDA Received Date: 02/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR