MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) (EXPORT ONL; BLOOD ACCESS AND ACCESSORIES

Catalog Number 5678200

Device Problems Device Packaging Compromised (2916); Incorrect Device Or Component Shipped (2962)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/30/2015

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 manufacturer has received the sample and will be evaluated.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

On (b)(6) 2015 allegedly, the number in heparin lock (red one) should be 1.2 ml.Supposedly, the complaint device is 2.2 ml.(please see the photo) reportedly, this event was found when unopened the package.

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 a misassembled dialysis catheter was confirmed and the cause appears to be manufacturing related.The item returned for evaluation was a photograph illustrating the clamps, priming volume tags, and luer hubs of a dialysis catheter.The priming volume tags in the image were ¿2.2 ml¿ and ¿1.3 ml¿.The catheter appeared clean and no signs of use were observed.Although the product identity could not be confirmed from the image, a review of the priming volumes for all configurations involving 1.3 ml and 2.2 ml tags found that no combination including both tags should exist.The bill of materials for the implicated product code found that the appropriate priming volume tags should read ¿1.2 ml¿ and ¿1.3 ml¿ which suggested that the ¿2.2 ml¿ tag seen in the image was incorrectly assembled on the product.

• Brand Name: FLEXXICON DIALYSIS CATHETER KIT 11F X 20CM (SHORT-TERM) (DUAL-LUMEN) (EXPORT ONL
• Type of Device: BLOOD ACCESS AND ACCESSORIES
• 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: christy chandonia ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225631
• MDR Report Key: 5176037
• MDR Text Key: 29846412
• Report Number: 3006260740-2015-00482
• Device Sequence Number: 1
• Product Code: LFJ
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K881743
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2020
• Device Catalogue Number: 5678200
• Device Lot Number: REZD2005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 10/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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