MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 25 BOX; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	N/A
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of jugt8542 showed no other similar product complaint(s) from this lot number.
Event or Problem Description
It was reported by medwatch "iv tubing separated from luer lock hub that was attached to a patient's iv catheter.Clean edges, tubing had not been cut.Patient's iv clotted, so no backflow of blood or blood loss from patient." on (b)(6) 2022, on 10/24/2022, additional information provided: date of occurrence: (b)(6) 2022, placement date: (b)(6) 2022,explant date: (b)(6) 2022.Patient information (if available): age: 64; sex: male, weight: 210lb/ 95.3kg.What they¿re being treated for: surgery/arthoplasty of knee.Other relevant history: none applicable.Concomitant therapy: intermittent saline flush of line as per md order; no continuous infusions or other intermittent infusions at time of discovery does the patient have an infectious disease?: none reported.
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of extension tubing detaching from the luer adapter was confirmed; however, the root cause was not identified.The product returned for evaluation was one statlock extension set with y-site.Usage residues were observed throughout the sample.The extension tubes exhibited material discoloration.The male luer adapter was received completely detached from the distal extension tube.Tactile inspection of the sample revealed tensile weakness throughout the distal extension tube.Microscopic inspection of the sample confirmed that the tubing was completely detached from the male luer adapter.No tubing fragment remained within the luer.Inspection of the distal end of the extension tubing revealed adhesive residue covering the last approximately ¼¿ of tubing.Attempts to replicate the observed detachment by applying tensile stress to a similar non-complainant device were unsuccessful.The adhesive residues suggested that adhesive was properly applied during device assembly.The tensile weakness suggested that pulling stress may have contributed to the observed detachment; however, the failure of attempts to replicate the damage by applying tensile stress indicated that an additional unidentified factor(s) contributed.Consequently this complaint is confirmed as ¿cause unknown¿ at this time.The material discoloration suggested that environmental factors such as chemical exposure may have contributed.H3 other text : evaluation findings are in section h.11.
Event or Problem Description
It was reported by medwatch "iv tubing separated from luer lock hub that was attached to a patient's iv catheter.Clean edges, tubing had not been cut.Patient's iv clotted, so no backflow of blood or blood loss from patient." 10/24/22 additional information provided: event information ¿ date of occurrence: (b)(6) 2022 ¿ placement date: (b)(6) 2022 ¿ explant date: 1(b)(6) 2022 patient information (if available) ¿ was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome.None reported ¿ age: 64 ¿ sex: male ¿ weight: 210lb/ 95.3kg ¿ what they¿re being treated for: surgery/arthoplasty of knee ¿ other relevant history: none applicable ¿ concomitant therapy: intermittent saline flush of line as per md order; no continuous infusions or other intermittent infusions at time of discovery ¿ *does the patient have an infectious disease?: none reported.

• Brand Name: STATLOCK IV SELECT MACRO 6IN SMARTSITE Y AND VALVE 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15712340
• Report Number: 3006260740-2022-04242
• Device Sequence Number: 12559165
• Product Code: FPA
• UDI-Device Identifier: 00801741082047
• UDI-Public: (01)00801741082047
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K980992
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/20/2023

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 Expiration Date: 05/28/2025
• Device Model Number: N/A
• Device Catalogue Number: IV0564
• Device Lot Number: JUGT8542
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/14/2022
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 11/01/2022
• Supplement Report FDA Received Date: 01/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2022
• 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: 64 YR
• Patient Sex: Male
• Patient Weight: 95 KG