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

Model Number	5913230
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
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 return of the sample is pending.The investigation of the reported event is currently underway.Expiry date: 08/2022.
Event or Problem Description
It was reported that during catheter placement procedure, a small fragment was allegedly found in one of the hubs while aspirating.It was further reported that the fragment did not enter the patients body.There was no reported patient injury.
Event or Problem Description
It was reported that during dialysis catheter placement procedure in the right chest , a small fragment was allegedly found in one of the hubs while aspirating.It was further reported that the fragment did not enter the patients body.There was no reported patient injury.
Additional 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: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported foreign material as no objective evidence was provided for review.A definitive root cause could not be determined based upon the 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: 08/2022).H11: section a through f ¿ the information provide by bd represents all 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: EQUISTREAM XK HEMODIALYSIS CATH W/STYLET, ST, AIRGUARD, 16 FR. 23CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12006433
• Report Number: 3006260740-2021-02298
• Device Sequence Number: 14278874
• 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): 09/30/2021

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: REEZ3608
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/21/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 06/16/2021
• Supplement Report FDA Received Date: 10/05/2021
• 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