MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION WITH STOPCOCK SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been received by the manufacturer for evaluation.H3 other text : device not returned.
Event or Problem Description
It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information on 9/15,we have reviewed and, in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the first device.
Additional Manufacturer Narrative
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.Based on a review of applicable information, the following was concluded: the complaint of a damaged extension tube was determined to be inconclusive.One photograph of an arterial statlock was returned for evaluation.An initial visual observation of the photograph showed the statlock, extension tube, and the packaging side by side.There was a red square and arrow drawn around the junction of the extension tube and male luer connector.There were no distinguishing features on the sample in the returned photograph that could be used to identify a root cause of the alleged issue; therefore, the complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.H3 other text: evaluation findings are in section h11.
Event or Problem Description
It was reported by customer that the arterial statlock extension tubing spontaneously breaking.Additional information on 9/15: we have reviewed and, in every case, it is the same reported complaint ¿ the extension tubing spontaneously breaks/tears at the patient end of the tubing.Since this is an arterial line which is needed to monitor and treat critically ill icu patients, there is a significant bleeding risk to the patient.With these tubing breaks, patients have been found bleeding, had blood loss, delay in treatment due to needing to obtain and replace hemodynamic tubing and/or insert a new arterial line.No additional patient information is available nor relevant for these cases.It was reported this occurred with four devices.This report addresses the first device.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION WITH STOPCOCK SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 17798663
• Report Number: 3006260740-2023-04239
• Device Sequence Number: 20705506
• Product Code: FPA
• UDI-Device Identifier: 00801741081378
• UDI-Public: (01)00801741081378
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2024

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: N/A
• Device Catalogue Number: ART0421
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2023
• Supplement Date Received by Manufacturer: 01/10/2024
• Initial Report FDA Received Date: 09/22/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown