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

Model Number N/A

Device Problem Misconnection (1399)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

Event Description

It was reported that 2 patients have recently needed catheter changes due to damage being caused to their catheter by the statlock device.Both times the patient or their family stated they had unlocked and when locking it again they may have accidentally caught something.This report addresses the second patient.

Event Description

It was reported that 2 patients have recently needed catheter changes due to damage being caused to their catheter by the statlock device.Both times the patient or their family stated they had unlocked and when locking it again they may have accidentally caught something.This report addresses the second patient.

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), labeling, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged or defective statlock device is inconclusive as the original product involved in the reported event was not returned for evaluation.Three sealed dialysis statlock kits were returned for evaluation.An initial visual observation showed all of the kits were returned sealed.The labels of the returned samples exhibited the product number di0120, the lot number juarf457, and an expiration date of march 2019.Once the statlock devices were removed from the sealed kits, the retainer of each sample was found to be able to be closed and locked successfully and securely.Because the original product involved in the reported event was not returned for evaluation, the reported event could not be confirmed, and a root cause(s) could not be identified.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.

• 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: 9142074
• MDR Text Key: 161715051
• Report Number: 3006260740-2019-02899
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: PIC0220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Event Location: Hospital
• Date Manufacturer Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1