MAUDE Adverse Event Report: BARD ACCESS SYSTEMS GLIDEPATH, 14.5F, 27CM, ST, STD KIT; DIAYSIS CATHETER

Model Number	5393270
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided, a review of the device history records is not required as this is the only complaint with the provided lot#.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 08/31/2020).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 or Problem Description
It was reported that during preparation, during dialysis catheter flush, saline allegedly leaked out of several pinholes found in the catheter.There was no patient contact.
Event or Problem Description
It was reported that during preparation, during dialysis catheter flush, saline allegedly leaked out of several pinholes found in the catheter.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: per the complaint history review (chr), a dhr review is not required.Labeling review: a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.Investigation summary: one 14.5 fr d/l glidepath 27 cm str hemodialysis catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for external leaking, as a pinhole was identified 10 mm distal to the collar on the red hub extension leg.The sample was patent to infusion and leaking was observed from the pin hole site only.Circumferential clamping creases were observed on both extension legs.The definitive root cause could not be determined based upon available information.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.

• Brand Name: GLIDEPATH, 14.5F, 27CM, ST, STD KIT
• Common Device Name: DIAYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8786274
• Report Number: 3006260740-2019-01959
• Device Sequence Number: 1707796
• Product Code: MSD
• UDI-Device Identifier: 00801741012198
• UDI-Public: (01)00801741012198
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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
• Operator of Device: Health Professional
• Device Model Number: 5393270
• Device Catalogue Number: 5393270
• Device Lot Number: REDN2430
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 10/08/2019
• Initial Report FDA Received Date: 07/12/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1