MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT; PERCUTANEOUS IMPLANTED LONG TERM INTRAVASCULAR CATHETER

Catalog Number 7617405

Device Problems Contamination (1120); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/27/2016

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 foreign material in the catheter was confirmed, but the exact cause and origin of the material is unknown.One 4 fr s/l groshong picc was returned for investigation.The picc was received with the two-piece connector attached and secured to the groshong 4 fr s/l tubing.A blue colored material was visible in the extension leg just proximal to the wing.The extension leg was cut open to examine the material.Two thin flecks of blue material were found in the extension leg.The length and width of the flecks were larger than the opening into the adjoining hard plastic components of the two-piece connector.Flecks of a similar color and composition were also visible on two separate pieces of gauze that were returned for investigation.One gauze pad was saturated with liquid.The length and width of the blue flecks that were returned on the gauze pads were also larger than the inner diameter of the adjoining hard plastic components of the two-piece connector.Since the id at the adjoining area of the two piece connector was smaller than the blue flecks, the flecks could not be flushed past the two-piece connector.The flecks could not have been aspirated from the distal segment of the catheter.It is unknown when the material was introduced into the extension leg.No components of the groshong picc have the same color and material hardness.The blue compression sleeve within the two piece connector has a similar color but a different hardness.An inspection of the connector revealed that the blue compression sleeve was complete and showed no damage or missing pieces.It was reported that the catheter was used for four months before the blue material was identified, which indicates that the material may have been introduced from an extrinsic source.No damage related to the manufacturing process was noted on the returned sample.A lot history review (lhr) of (b)(4) showed no other similar product complaint(s) from these lot numbers.

Event Description

It was reported by nurse that the catheter inserted in (b)(6) 2015 was used normally all the time.On (b)(6) 2016, the patient went back to the outpatient of the hospital for maintenance.When withdrawing blood return, it was found there was blue catheter debris inside the extension tube, and several debris could be withdrawn.

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 initial complaint appeared to be a reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had not occurred.

• Brand Name: 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT
• Type of Device: PERCUTANEOUS IMPLANTED 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: shelly gilbert ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225640
• MDR Report Key: 5449038
• MDR Text Key: 39102671
• Report Number: 3006260740-2016-00044
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741086991
• UDI-Public: (01)00801741086991(17)181028(10)REYK0371
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K034020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/27/2016

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: 10/28/2018
• Device Catalogue Number: 7617405
• Device Lot Number: REYK0371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2016
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 02/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2014
• 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
• Patient Age: 30 YR
• Patient Weight: 53