MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH, 14.5F, 23CM, ST, STD KIT; CATHETER, HEMODIALYSIS, IMPLANTED

Model Number 5393230

Device Problems Migration or Expulsion of Device (1395); Expulsion (2933); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Skin Erosion (2075); No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  Injury  

Manufacturer Narrative

The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.(expiry date: 06/2021).The information provided by bd 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 bd.

Event Description

It was reported that approximately 15 weeks post dialysis catheter placement the catheter allegedly fell out of the patient as the sutures were being removed.There was no reported patient injury.

Manufacturer Narrative

H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 23cm glidepath catheter was returned in two segments for evaluation.Gross visual inspection, microscopic visual inspection and functional evaluations were performed.The investigation is inconclusive for the catheter falling out of the patient.Circumferential break was noted at approximately 21.1cm from the distal end of the y-body and both lumens on the distal catheter segment presented difficulty in infusion and would not aspirate.Although a definitive root cause could not be determined, inappropriate securement method, improper cuff retention, or excessive procedural forces could have potentially caused or contributed to the reported event.It is unknown whether patient and/or procedural factors contributed to the event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) found that the product labeling was inadequate.H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that approximately 15 weeks post dialysis catheter placement the catheter allegedly fell out of the patient as the sutures were being removed.It was further reported that pressure was held for ten minutes and dressing was applied.The patient's status is unknown.

• Brand Name: GLIDEPATH, 14.5F, 23CM, ST, STD KIT
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9750995
• MDR Text Key: 194018390
• Report Number: 3006260740-2020-00614
• Device Sequence Number: 1
• Product Code: MSD
• UDI-Device Identifier: 00801741012181
• UDI-Public: (01)00801741012181
• Combination Product (y/n): N
• PMA/PMN Number: K051748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5393230
• Device Catalogue Number: 5393230
• Device Lot Number: REDU4305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Initial Date Manufacturer Received: 01/29/2020
• Initial Date FDA Received: 02/25/2020
• Supplement Dates Manufacturer Received: 07/31/2020
• Supplement Dates FDA Received: 07/31/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Weight: 171