MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F

Model Number	5833350
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/04/2020
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 return of the sample is pending; however, a photo has been provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2021).
Event or Problem Description
It was reported that during implantation procedure, the plastic fitting of the introducer needle was allegedly broken.Reportedly the alleged issue leads to air leaks during aspiration.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review:a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary:one introducer needle and one unknown 5ml syringe was returned for evaluation.Visual, microscopic visual and functional evaluations were performed.One electronic photo was provided for review.The photo shows a introducer needle with pink color hub and the cracks are not clearly visible because of the quality of the photo.The investigation is confirmed for fracture as during sample evaluation several cracks were noted on the introducer needle hub and leak was also noted from the cracks.A definitive root cause could not be determined based upon available information.Labeling review:a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: d4(expiry date: 04/2021).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 or Problem Description
It was reported that during implantation procedure, the plastic fitting of the introducer needle was allegedly broken.Reportedly the alleged issue leads to air leaks during aspiration.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, 14.5F
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10475984
• Report Number: 3006260740-2020-03092
• Device Sequence Number: 11360536
• Product Code: MSD
• UDI-Device Identifier: 00801741013362
• UDI-Public: (01)00801741013362
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2020

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: 5833350
• Device Catalogue Number: 5833350
• Device Lot Number: REDT4058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Initial Date Received by Manufacturer: 08/08/2020
• Supplement Date Received by Manufacturer: 12/03/2020
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 12/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Weight: 55