MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
Event or Problem Description
It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.
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.
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 complaint of a leak in the extension set tubing was inconclusive due to the sample condition.Two photographs of the arterial statlock kit (art0420) were provided.The provided photographs showed the product type that was included in the affected medline ynhh arterial line insertion bundles.These photographs were not of the affected products and no damage was apparent in the returned photographs.There was reference in the email attachments to other photographs of the affected product.However, these photographs were not attached to the complaint file and therefore could not be evaluated at this time.In addition, physical samples were sent to medline and therefore, bd does not have access to these samples for evaluation.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that the product is cracked.It appears to be the extension tubing itself which would be different than the statlock devices which would go over the tubing and hub.Leaking stat-lock arterial line device.Newly inserted arterial line stat-lock device noted to have blood backing up and leaking on pillow.Upon switching to new line, noted crack in tubing where blood was leaking from.Product issue with cracking causing blood to back up into tubing, inaccurate blood pressure, switched to new stat-lock with no issues.It was reported this occurred with two devices.One device was used on a patient and one was not used on a patient.This report addresses the device that was used on a patient.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18822017
• Report Number: 3006260740-2024-00877
• Device Sequence Number: 4579424
• Product Code: FPA
• UDI-Device Identifier: 00801741081354
• UDI-Public: (01)00801741081354
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ART0420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2024
• Supplement Date Received by Manufacturer: 03/04/2024; 05/16/2024
• Initial Report FDA Received Date: 03/01/2024
• Supplement Report FDA Received Date: 03/15/2024; 05/30/2024
• 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: Required Intervention
• Patient Sex: Unknown