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

Model Number N/A

Device Problems Defective Component (2292); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/24/2020

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of judqf228 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that there was an adhesion/glue issue with the skin aplicare (the skin protectant pack) in the statlock kit.

Event Description

It was reported that there was an adhesion/glue issue with the skin aplicare (the skin protectant pack) in the statlock kit.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of an issue with the skin prep pad or the statlock stabilization device was inconclusive since the returned samples exhibited no damage or defects.One open statlock stabilization device pouch was returned for investigation.The statlock device showed no damage or evidence of use.The paper backing remained attached to the substrate.The retainer was adhered to the substrate along the entire perimeter of the retainer.The skin prep pad was received in an unopened pouch.The prep pad was removed from the pouch and was found to be moist and pliant.Since the prep pad was received in an unopened pouch, any observed dryness would have occurred on a sample from an open prep pad pouch.Since no damage was observed on the returned samples, it is possible that the affected sample was not returned for investigation.A lot history review (lhr) of judqf228 showed no other similar product complaint(s) from this lot number.

• 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: 9856599
• MDR Text Key: 194527290
• Report Number: 3006260740-2020-00896
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2022
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Device Lot Number: JUDQF228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 56