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

Model Number	N/A
Medical Device Problem Codes	Disconnection (1171); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/02/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 second device.
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 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 or Problem 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 second device.

• Brand Name: STATLOCK PICC PLUS CRESCENT SLIDING POST
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10314374
• Report Number: 3006260740-2020-02641
• Device Sequence Number: 3574900
• Product Code: FOX
• UDI-Device Identifier: 00801741082948
• UDI-Public: (01)00801741082948
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/28/2020

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: 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
• Initial Date Received by Manufacturer: 07/02/2020
• Supplement Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 07/23/2020
• Supplement Report FDA Received Date: 08/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1