MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK INTRA AORTIC BALLOON STABILIZATION DEVICE; STAND, INFUSION

Catalog Number IB0200

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of judqf294 showed five other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility.

Event Description

It was reported "during use on the patient, the registered nurse (rn) placed the statlock stabilization device on the patient.It was noted that the pad on the statlock was not sticking on the patient and the rn stated the pad was "dry".Six statlock were used and none was sticking on the patient.As a result, the rn continued to use the non-stick statlock as is.There was no report of patient complications, serious injury or death" this report addresses the first of six devices.

• Brand Name: STATLOCK INTRA AORTIC BALLOON STABILIZATION DEVICE
• Type of Device: STAND, INFUSION
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 11865540
• MDR Text Key: 252160797
• Report Number: 3006260740-2021-01935
• Device Sequence Number: 1
• Product Code: FOX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: IB0200
• Device Lot Number: JUDQF294
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other