MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number F118108PT

Device Problems Kinked (1339); Failure to Advance (2524)

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

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 initial complaint appeared to be a non-reportable occurrence.Once the sample was returned and evaluated it was determined that a reportable event had occurred.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 guidewire complications was confirmed and the cause appeared to be use-related.The product returned for evaluation was two 18ga x 10cm powerglide pro midline catheter assemblies.Both samples were received with the safety mechanisms engaged and the catheters detached.Blood residues were observed throughout both samples.Both guidewires were disengaged from the advancers.Both guidewires appeared to be intact.Microscopic inspection of the first sample (sample 1) revealed a kink in the guidewire near the weld tip.Inspection of the needle revealed mechanical damage along the proximal edge of the bevel.Microscopic inspection of the second sample (sample 2) revealed superficial scoring marks on the coupler.The usage residues, guidewire kink and marks on the coupler were consistent with the guidewire being advanced against resistance during attempted use.Such resistance can occur if guidewire advancement into tissue is attempted and can result in guidewire damage and detachment from the advancer.A lot history review (lhr) of reby2533 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (reby2533) have been reported from the same facility.

Event Description

It was reported that the powerglide needle was inserted in the patient's vein, then the "wire wouldn't allow them to advance, it was like it was locked." it happened twice.On 5/2/2018 - returned samples have blood residue, indicating use on a patient.Both samples have guidewires that were dislodged from the coupler and one guidewire was found to be kinked at the tip.This report address the second device (sample 2).

• Brand Name: FULL KIT 18G X 10 CM WITH GUARDIVA AND PROBE COVER
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• 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: tesha udy ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225819
• MDR Report Key: 7541044
• MDR Text Key: 109390999
• Report Number: 3006260740-2018-01085
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00801741140563
• UDI-Public: (01)00801741140563
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: F118108PT
• Device Catalogue Number: F118108PT
• Device Lot Number: REBY2533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Date Manufacturer Received: 05/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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