MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD; DEVICE, INTRAVASCULAR, CATHETER SECUREMENT

Model Number	N/A
Medical Device Problem Codes	Misconnection (1399); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/11/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported on (b)(6) 2023, at 9:00, we changed the picc dressing for patient and performed catheter fixation, and found that the fixator button was not securely fastened.Poor fixation of the tube is likely to cause the tube to slip out, resulting in accidental extubation.After the discovery of the immediate replacement of materials, and notify the head nurse, the patient after follow-up observation, no obvious discomfort.
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 is pending evaluation.Results are expected soon.
Event or Problem Description
It was reported on (b)(6) 2023, at 9:00, we changed the picc dressing for patient and performed catheter fixation, and found that the fixator button was not securely fastened.Poor fixation of the tube is likely to cause the tube to slip out, resulting in accidental extubation.After the discovery of the immediate replacement of materials, and notify the head nurse, the patient after follow-up observation, no obvious discomfort.
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 damaged latch was confirmed.The product returned for evaluation was one cv plus statlock device.The investigation findings are consistent with damage caused by pushing the securement tab at an angle while attempting to close the device.This issue can be avoided by centering the thumb about the middle of the tab and pressing directly downward.The returned product sample was evaluated and a securement tab was observed to be damaged.The following observations were made which were consistent with this failure type: an attempt to test the functionality of the lock was unsuccessful and the latch(s) was observed to be misaligned with the catch base; the tab latch(s) was observed to be bent; the tab catch(s) exhibited plastic deformation at the point of contact with the latch.This failure type was recreated in the laboratory using non-complainant samples by closing the tab at an angle, or by pressing outside the center of the tab, and the features observed on the laboratory samples were similar to those on the returned complainant sample.The nature of the damage observed on the latch, and their points of contact on the catch base as well as the characteristics of the hinge damage, are evidence that the damage was caused by misalignment of the doors when closing the device.Pushing the tab at an angle can cause the latch to miss the catch base and can permanently bend the latch.An examination of the sample revealed no potential damage/defect related to manufacture of the product.H3 other text: evaluation findings are in section h11.

• Brand Name: STATLOCK CV PLUS SLIDING POST, TRICOT HYDROCOLLOID CRESCENT PAD, PIGTAIL PAD
• Common Device Name: DEVICE, INTRAVASCULAR, CATHETER SECUREMENT
• 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: 18314282
• Report Number: 3006260740-2023-05655
• Device Sequence Number: 6784488
• Product Code: KMK
• UDI-Device Identifier: 00801741081507
• UDI-Public: (01)00801741081507
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024
• 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: CV0220CE
• Device Lot Number: JUHN0583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2023
• Supplement Date Received by Manufacturer: 01/26/2024
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 02/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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