MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST; DEVICE, INTRAVASCULAR CATHETER SECUREMENT

Model Number N/A

Device Problem Misconnection (1399)

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

Event Date 01/19/2024

Event Type  malfunction  

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 Description

It was reported by the customer that sides will not stay locked.No adverse events reported.No other information was provided.It was reported that this occurred with six devices.This report addresses the first device.

Event Description

It was reported by the customer that sides will not stay locked.No adverse events reported.No other information was provided.It was reported that this occurred with six devices.This report addresses the first device.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.This complaint was received as part of a clinical survey.Contact information and specific patient details were not disclosed as part of the survey.As such, additional information and the subject sample cannot be obtained.The complaint of the door unable to latch closed was confirmed.The product returned for evaluation was crescent fixed post statlock stabilization device.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 and had plastic deformation which was seen at the point of contact with the catch ¿ 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.This complaint will be recorded for future trending and monitoring purposes.H3 other text : evaluation findings are in section h.11.

• Brand Name: STATLOCK PICC PLUS CRESCENT TRICOT FIX-POST
• Type of Device: 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18717402
• MDR Text Key: 335838258
• Report Number: 3006260740-2024-00552
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2024
• 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: PIC0222
• Device Lot Number: JUHQ8109
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2023
• 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