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 Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer "the stat lock plastic detached and a picc was pulled out 20cm." 1/27/2023 - forty-nine devices were returned for evaluation and all exhibited detachment.This report addresses the tenth device.
Additional Manufacturer Narrative
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 following were reviewed as part of this investigation: patient severity, applicable previous investigation(s), sample analysis, complaint and lot history review, applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of detached retainers is confirmed and was determined to be manufacturing related.Forty-nine picc plus statlock kits were returned for evaluation.An initial visual observation showed one of the kits was returned open and forty-eight of the kits were returned sealed.The left side retainer of the statlock device within the kit that was returned open was found to be detached from its pad.Each of the sealed kits were opened and an attempt was made to gently pull the retainer off of the pad of each device.At least one side of the retainer of each sample was found detach easily from its pad.The pads and the undersides of the retainers of the returned samples were observed to be tacky.A microscopic observation revealed adhesive on the underside of the detached retainers and within the fibers of the tricot pads on each sample.Strings of adhesive were observed between the pad and the retainer of each sample, suggesting the adhesive did not cure correctly.The investigation was forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A batch history review (bhr) of jugs2486 showed forty-eight other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in canada.H3 other text : evaluation findings are in section h11.

• 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: 16261319
• Report Number: 3006260740-2023-00213
• Device Sequence Number: 15128640
• Product Code: KMK
• UDI-Device Identifier: 00801741034947
• UDI-Public: (01)00801741034947
• 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: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/27/2023

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: 04/30/2024
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUGS2486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 01/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2022
• 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 Sex: Unknown