MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2024
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that leakage at tubing bonded site.Disconnection of tubing site connected to statlock.No other information was provided.It was reported this occurred with thirteen devices.This report addresses the first device.
Event or Problem Description
It was reported by customer that leakage at tubing bonded site.Disconnection of tubing site connected to statlock.No other information was provided.It was reported this occurred with thirteen devices.This report addresses the first device.
Additional Manufacturer Narrative
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 at the connection between the tubing and the male luer connector was inconclusive due to the sample condition.A slideshow slide was provided for evaluation.The slide indicated that ¿arterial statlock extension tubing spontaneously breaking at the patient end of the tubing¿.Three photographs of the product were included on the slide; an arterial statlock kit with the product pouch, an unopened bulk pouch containing an arterial statlock, and an arterial statlock extension set.The samples all appeared unused.A red arrow on the photograph of the extension set indicated the region where the complainant was experiencing the reported issue; the arrow pointed to the connection between the extension tubing and the male luer-lock connector.No tears or tubing dislodgements were visible in the provided photographs.As the submitted photographs did not contain enough information to confirm the event, this complaint will be recorded as inconclusive at this time.However, the event description of the leak was similar to a previously identified issue and may be related.Reference cid #8619244 for further information.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: STATLOCK ARTERIAL PLUS CRESCENT TRICOT BND STOPCOCK ALC PREP 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: 18725360
• Report Number: 3006260740-2024-00625
• Device Sequence Number: 17729830
• Product Code: FPA
• UDI-Device Identifier: 00801741081279
• UDI-Public: (01)00801741081279
• Combination Product (Y/N): N
• Initial Reporter State: AK
• 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
• Report Date (Section B): 04/22/2024

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: ART0220
• 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: 01/22/2024
• Supplement Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 05/08/2024
• 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