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

Model Number	N/A
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2023
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 device has not been returned to the manufacturer for evaluation.H3 other text : device not returned.
Event or Problem Description
It was reported by customer that a-line disconnected and catheter was still in artery, causing open flow of blood.Rn was in room at time of disconnected and catheter was quickly removed and pressure was applied.The event did not result in a delay in treatment.Additional information from customer response on 07-05-2023 the event did not involve an urgent or life threatening medical situation.
Event or Problem Description
It was reported by customer that a-line disconnected and catheter was still in artery, causing open flow of blood.Rn was in room at time of disconnected and catheter was quickly removed and pressure was applied.The event did not result in a delay in treatment.Additional information from customer response on 07-05-2023 : the event did not involve an urgent or life threatening medical situation.
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.
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 this information, the following was concluded: the complaint of a detached luer lock adaptor was confirmed and appears to be manufacturing related.Three photographs were provided for investigation.Two of the photos appeared to show a non-complainant sample which included the statlock stabilization device, an arterial extension set with a three-way stopcock, and the packaging.No damage was seen at the connections between the male luer-lock adaptor, the tubing sleeve, or the extension tubing; however, the connection was highlighted in the photograph and had a red arrow pointing to it.The third photograph showed a different arterial extension set.This extension set appeared used as residual material was present throughout the sample.The male luer lock adapter had completely separated from the tubing sleeve.The proximal end of the tubing sleeve appeared straight and no tubing appeared to be present within the male luer-lock adapter.This indicated that the adhesive joint between the components failed and the tubing sleeve likely dislodged from the luer adaptor.Bd is working closely with manufacturing to prevent recurrence of the reported event.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 a-line disconnected and catheter was still in artery, causing open flow of blood.Rn was in room at time of disconnected and catheter was quickly removed and pressure was applied.The event did not result in a delay in treatment.Additional information from customer response on 07-05-2023: the event did not involve an urgent or life threatening medical situation.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION W/STOPCOCK
• 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: 17339422
• Report Number: 3006260740-2023-03017
• Device Sequence Number: 2494069
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/30/2023
• 2 Devices were Involved in the Event: 1 2

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: 06/29/2023
• Supplement Date Received by Manufacturer: 07/24/2023; 10/30/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/03/2023; 11/01/2023
• 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 Age: 77 YR
• Patient Sex: Female