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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/04/2023

Event Type  malfunction  

Event Description

It was reported by the customer that an incident where the item malfunctioned while in use on a patient.Additional information provided 2/13/2023: physician had gone into a patient's room and noted blood on the pillow.Looking at the artline, it was noted that the tubing that comes in the statlock arterial select package was disconnected and a clean detachment from the hub was noted.The patient did not appear to have been able to pull or disconnect the tubing.There was no patient harm from this incident.A new stat lock was applied and the artline was saved and no change in the patient's status was noted.Patient was intubated on ventilator at the time of the event and was initially admitted with a seizure.The artline and tubing had been inserted 24hours prior to the event.No other information was provided.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of jugn8533 showed no other similar product complaint(s) from this batch number.

Event Description

It was reported by the customer that an incident where the item malfunctioned while in use on a patient.Additional information provided 2/13/2023 physician had gone into a patient's room and noted blood on the pillow.Looking at the artline, it was noted that the tubing that comes in the statlock arterial select package was disconnected and a clean detachment from the hub was noted.The patient did not appear to have been able to pull or disconnect the tubing.There was no patient harm from this incident.A new stat lock was applied and the artline was saved and no change in the patient's status was noted.Patient was intubated on ventilator at the time of the event and was initially admitted with a seizure.The artline and tubing had been inserted 24hours prior to the event.No other information was provided.

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.

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 available complaint information and an evaluation of the available sample evidence, the following was concluded: the complaint of a damaged statlock extension tube was inconclusive because the returned samples were all sealed and appeared to be unused batch samples.The product returned for evaluation was six arterial statlock catheter stabilization kits.All six kits were received sealed.Following opening of the sealed packaging, inspection of the kit components was unremarkable.The extension sets appeared properly assembled.Microscopic inspection of the samples was unremarkable.Attempts to infuse water through the extension sets using a 12ml syringe revealed all six to be patent to both infusion and aspiration with no observed leaks.No leaks were observed during pressurization.Attempts to separate the extension tubes from the male luer adapters were unsuccessful.The bonds were firm and were not modified by exposure to pulling stress.No deficiencies were discovered during evaluation of the returned samples; however, the samples were unused.The implicated device was not returned for evaluation.Consequently this complaint is inconclusive at this time.

Event Description

It was reported by the customer that an incident where the item malfunctioned while in use on a patient.Additional information provided 2/13/2023 : physician had gone into a patient's room and noted blood on the pillow.Looking at the artline, it was noted that the tubing that comes in the statlock arterial select package was disconnected and a clean detachment from the hub was noted.The patient did not appear to have been able to pull or disconnect the tubing.There was no patient harm from this incident.A new stat lock was applied and the artline was saved and no change in the patient's status was noted.Patient was intubated on ventilator at the time of the event and was initially admitted with a seizure.The artline and tubing had been inserted 24hours prior to the event.No other information was provided.

• Brand Name: STATLOCK LUER RETAINER, SELECT PADS 8IN LUER LOCK EXTENSION SET 25 BOX
• Type of Device: 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: suedabba mahboobi ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16457588
• MDR Text Key: 310420095
• Report Number: 3006260740-2023-00574
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K980994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: ART0420
• Device Lot Number: JUGN8533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR
• Patient Sex: Male
• Patient Weight: 84 KG