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

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	02/13/2024
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 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.No other information was provided.
Event or Problem Description
It was reported 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.No other information was provided.
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 leaking extension set is inconclusive due to the state of the returned sample.One photograph of a statlock kit was returned for evaluation.An initial visual observation of the photograph showed a sealed statlock kit.No use residue was observed.No damage to the device could be seen in the returned photograph.Inspection of the returned photograph was insufficient to identify the alleged issue or a root cause of the reported issue.Therefore, this complaint is inconclusive at this time.This complaint will be recorded for future trending and monitoring purposes.
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 leaking from arterial statlock extension tubes is confirmed but the exact cause could not be determined.Two arterial statlocks were returned for evaluation.An initial visual observation showed some blood use residues throughout sample 1 and sample 2.The luer of sample 1 and sample 2 appeared cracked.The luer of sample 2 appeared to have missing threads.A functional test of attempting to infuse water into each returned sample using a 12 ml syringe revealed the luer for each device leaked severely.During functional testing of sample 1, one of the threads on the luer of sample 1 broke off the device.A microscopic observation revealed several longitudinal cracks along the luer of each returned device.The breaks in the luer had uneven fracture surfaces for each sample from what appeared to be brittle failures in the material of the luer.Because use residues were observed throughout each returned sample and cracks were observed along the luer of each device, the complaint of leaking arterial statlocks is confirmed but the root cause could not be determined.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported 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.No other information was provided.06/12/2024 - two arterial statlocks were returned for evaluation.The luer of both samples were cracked.This report addresses the first sample.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION 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): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18870571
• Report Number: 3006260740-2024-01009
• Device Sequence Number: 16906021
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/12/2024
• 2 Devices were Involved in the Event: 1 2

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: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2024
• Supplement Date Received by Manufacturer: 03/19/2024; 06/12/2024
• Initial Report FDA Received Date: 03/08/2024
• Supplement Report FDA Received Date: 04/03/2024; 06/20/2024
• 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