MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STATLOCK PICC PLUS CRESCENT SLIDING POST; STAND, INFUSION

Model Number N/A

Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and is pending evaluation.Results are expected soon.A lot history review (lhr) of judy0418 showed ten other similar product complaint(s) from this lot number.

Event Description

It was reported that the clip of the statlock has completely detached from the ticot pad when using on a patient.No other information was provided.It was reported this occurred with ten devices.This report addresses the fourth device.

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 following were reviewed as part of this investigation: patient severity, complaint and lot history review, applicable previous investigation(s), sample (if available), 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.Five picc plus statlock devices with tricot pads and adjustable posts were returned for evaluation.An initial visual observation showed the retainer of two of the returned samples were completely detached from their respective pads and another sample was found to be missing its retainer entirely, with only the pad returned.One sample was found to be partially detached from its pad, and the retainer of one sample that was returned in a sealed kit was found to detach from its pad with relative ease.A microscopic observation revealed some evidence of adhesive on the returned pads and adhesive on the underside of the retainers; however, the adhesive coverage was observed to be poor, particularly at the left, right, and bottom sides of the retainers.The poor adhesive coverage on the majority of the underside of the returned retainers suggests an insufficient amount of adhesive was applied to the retainers during manufacturing.A lot history review (lhr) of judy0418 showed ten other similar product complaint(s) from this lot number.

Event Description

It was reported that the clip of the statlock has completely detached from the ticot pad when using on a patient.No other information was provided.It was reported this occurred with ten devices.This report addresses the fourth device.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Type of Device: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10314394
• MDR Text Key: 200450468
• Report Number: 3006260740-2020-02643
• Device Sequence Number: 1
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2022
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUDY0418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2020
• Event Location: Hospital
• Date Manufacturer Received: 08/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1