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

Model Number	N/A
Medical Device Problem Codes	Misassembled (1398); Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported inside statlock are 2 little blue tabs (sliding post retainers) that have posts that insert into "wings" of the picc ine.The right blue tab is locked and immobile within the statlock.As a result, nurse had difficulty placing picc "wings" and pulled line 4cm.We put another on.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 manufacturer has received the sample and will be evaluated.A supplemental will be submitted with evaluation results.
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 stuck sliding post is confirmed and was determined to be manufacturing related.One statlock device with a tricot pad and adjustable posts was returned for evaluation.An initial visual observation showed the right sliding post was outside of its track and wedged underneath the retainer.A microscopic observation revealed no damage on the right retaining bumps of the retainer.Some damage was observed on the upper track of the retainer.The location of the right sliding post and the lack of damage on the retaining bumps of the retainer suggest that the right sliding post was assembled incorrectly during manufacturing, which caused the sliding post to become stuck.Photographs of the returned sample have been forwarded to the manufacturing facility for further evaluation.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• 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: 21143234
• Report Number: 3006260740-2024-08370
• Device Sequence Number: 13033796
• Product Code: KMK
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948(11)230819(17)260728(10)JUHU0864
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 04/21/2025

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: 07/28/2026
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUHU0864
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 04/21/2025
• Initial Report FDA Received Date: 01/13/2025
• Supplement Report FDA Received Date: 05/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2023
• 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