MAUDE Adverse Event Report: BARD ACCESS SYSTEMS UKNOWN MIDLINE; INTRAVASCULAR CATHETER LESS THAN 30 DAYS

Catalog Number UNKNOWN

Device Problems Entrapment of Device (1212); Failure to Advance (2524); Material Twisted/Bent (2981)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

Facility reported to the sales rep that they attempted to place a power midline on a patient.The rn gained access and inserted the wire which wouldn¿t advance.She removed the wire and attempted to advance the wire again without success.When she attempted to remove the needle and the wire simultaneously neither would move.The rn covered the insertion site and the patient was transported to ir.The ir physician x-ray¿s the site and noticed the wire was ¿pretzeled¿ in the tissue.A small incision was made allowing the wire to be removed.No patient injury was reported.

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 ¿pretzeled¿ guidewire was confirmed and appeared to have occurred during use.The product returned for evaluation was a 0.018" x 50cm nitinol guidewire.The sample contained blood-like residue throughout indicating use.A tight knot in the guidewire was seen at the proximal end of the wire, within the "j" tip.Blood and tissue-like residue was seen within the knot.Microscopic examination of the sample was unremarkable.The weld tip was intact and no potential manufacture causes or contributing factors were observed.This type of failure can possibly occur as an anomaly of guidewire movement through a tortuous path.In order for a knot to form there would need to be forward motion against an obstacle, a twisting motion in order to bring the wire through the potential loop, and a backward motion (such as withdrawal of the wire).Avoiding twisting motions (particularly when encountering insertion difficulty) may help to avoid the alleged event.No evidence of a manufacture deficiency was observed during the investigation.

Event Description

Facility reported to the sales rep that they attempted to place a power midline on a patient.The rn gained access and inserted the wire which wouldn¿t advance.She removed the wire and attempted to advance the wire again without success.When she attempted to remove the needle and the wire simultaneously neither would move.The rn covered the insertion site and the patient was transported to ir.The ir physician x-ray¿s the site and noticed the wire was ¿pretzeled¿ in the tissue.A small incision was made allowing the wire to be removed.No patient injury was reported.

• Brand Name: UKNOWN MIDLINE
• Type of Device: INTRAVASCULAR CATHETER 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: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6544086
• MDR Text Key: 74412209
• Report Number: 3006260740-2017-00563
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2017
• Is the Reporter a Health Professional?: No
• Event Location: Hospital
• Date Manufacturer Received: 05/24/2017
• 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