MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR,ST,19CM, STAND KIT; DIALYSIS CATHETER

Model Number	5703690
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device has not been returned to the manufacturer for evaluation; however a video was provided and is pending review.The investigation of the reported event is currently underway.(expiration date: 05/2021).
Event or Problem Description
It was reported that during dialysis catheter insertion procedure, an alleged air leak occurred with the introducer needle.It was further reported that the device was exchanged with a new dialysis catheter and the procedure was completed.There was no reported patient injury.
Event or Problem Description
It was reported that during dialysis catheter insertion procedure, an alleged air leak occurred with the introducer needle.It was further reported that the device was exchanged with a new dialysis catheter and the procedure was completed.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the previously submitted emdr inaccurately reported the g4 date.The g4 date should have been reported as 10/07/2019.Manufacturing review: based upon the severity level and lot quantity, the number of events is not above the aql threshold.The lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.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: although the sample was not returned for evaluation, one electronic video was provided for review.The investigation is inconclusive for specific failure mode, as the video review could not confirm a functional issue.Although a definitive root cause could not be determined, bad needle/luer bond, damaged or defective luer adaptor, inappropriate material selection or insufficient.
Additional Manufacturer Narrative
Manufacturing review: based upon the severity level and lot quantity, the number of events is not above the aql threshold.The lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc inspection process.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: although the sample was not returned for evaluation, one electronic video was provided for review.The investigation is inconclusive for specific failure mode, as the video review could not confirm a functional issue.Although a definitive root cause could not be determined, bad needle/luer bond, damaged or defective luer adaptor, inappropriate material selection or insufficient.
Event or Problem Description
It was reported that during dialysis catheter insertion procedure, an alleged air leak occurred with the introducer needle.It was further reported that the device was exchanged with a new dialysis catheter and the procedure was completed.There was no reported patient injury.

• Brand Name: HEMOSPLIT, 14.5 FR,ST,19CM, STAND KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8841339
• Report Number: 3006260740-2019-02224
• Device Sequence Number: 372247
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: RECS1056
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 10/07/2017; 12/04/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 11/01/2019; 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 60