MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS, ST, 16 FR, 23 CM, BASIC KIT; LONG TERM INTRAVASCULAR CATHETER

Catalog Number 5143230

Device Problems Device Operates Differently Than Expected (2913); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Information (3190)

Event Date 10/07/2016

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 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 material in the catheter could be confirmed from the returned photographs, but the origin and composition of the material could not be verified from the photos.Two images were provided for investigation.The returned images appear to be photographs of a monitor, which shows the distal tip of what could be a access catheter.Photo #1 shows two gloved fingers, the distal tip of a catheter, and what appears to be foreign material protruding from the distal tip of the catheter.Drops of liquid are seen on the blue drape, over which the catheter was placed.The second photo shows the distal end of the catheter and what could be a 1-2 cm strip of white/translucent material on the blue drape.The strip of material could be the material that was protruding from the distal tip of the catheter in the first image.It was reported that the catheter was used and noted to not be working well.It was at the time of removal that the material was observed, but the source or composition of the material could not be determined from the photographs.The photos will be provided to the manufacturing facility for further review.A lot history review (lhr) of rezi1887 showed no other similar product complaint(s) from this lot number.

Event Description

Facility reported that patient's catheter was not working well, when the healthcare professional removed the device they found a "plastic piece" in the tip of the catheter.

• Brand Name: VACCESS, ST, 16 FR, 23 CM, BASIC KIT
• Type of Device: 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6128735
• MDR Text Key: 61233390
• Report Number: 3006260740-2016-00628
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741010972
• UDI-Public: (01)00801741010972(17)200928(10)REZI1887
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/03/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: 5143230
• Device Lot Number: REZI1887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2016
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/08/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2015
• 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