MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 EQUISTREAM XK HEMODIALYSIS CATH W/STYLET, ST, AIRGUARD, 16 FR. 23CM; HEMODIALYSIS CATHETER

Model Number	5913230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history record is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 04/2022).
Event or Problem Description
It was reported that during the catheter placement through right internal jugular, the catheter allegedly cracked at the hub.The defective catheter was removed and the procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that during the catheter placement through right internal jugular, the catheter allegedly cracked at the hub.The defective catheter was removed and the procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: this is the first complaint reported to date for this product and lot, therefore a device history record review is not required.Investigation summary: one equistream d/l catheter in a sample return kit was returned for evaluation.Visual, microscopic and functional evaluations were performed.The investigation is inconclsive for catheter split issue as a circumferential split was noted on the blue extension leg approximately 6.0cm from the distal end of the blue luer but striations were noted at the edge of the circumferential split which appeared to be cut.Although a definitive root cause could not be determined, sharp instrument damage and/or excessive force could have potentially caused or contributed to the reported 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) did not find any product labeling inadequacy.H10: d4 (expiry date: 04/2022).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.H3 other text : see h10.

• Brand Name: EQUISTREAM XK HEMODIALYSIS CATH W/STYLET, ST, AIRGUARD, 16 FR. 23CM
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10815287
• Report Number: 3006260740-2020-20438
• Device Sequence Number: 14488621
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2020

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: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: REET1615
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2020
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 71 YR
• Patient Weight: 89