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

Model Number	F120101
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/27/2018
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 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 kink in the catheter was confirmed, and it appeared that the kink developed during use.A 20g powerglide catheter was returned for investigation.Sample exhibited evidence of use.The catheter had been removed from the deployment system and the wings had been removed from the purple connectors.The catheter was curved.Residue was observed on the external surface of the purple connector.On the sample, a semi-circumferential crease was observed in the tubing 1.8cm from the distal end of the pink strain relief sleeve.The catheter was easily kinked at the crease.The catheter was most likely positioned in a location where the kink would develop during use.The catheter was patent to infusion and no leaks were noted in any part of the catheter.The lumen was not patent to infusion once the catheter was kinked.The product ifu states, ¿avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort.¿ a lot history review (lhr) of reby1133 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby1133) have been reported from the same facility.
Event or Problem Description
It was reported that there was an internal kink in the catheter.No other information was provided.

• 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: 7450687
• Report Number: 3006260740-2018-00783
• Device Sequence Number: 11033690
• Product Code: FOZ
• UDI-Device Identifier: 00801741110580
• UDI-Public: (01)00801741110580
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K153280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2018

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 Model Number: F120101
• Device Catalogue Number: F120101
• Device Lot Number: REBY1133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2018
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2018
• Initial Report FDA Received Date: 04/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1