MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK IV SELECT LUER RETAINER SELECTPADS MICROBORE 6IN LUER LOCK; STAND, INFUSION

Model Number N/A

Device Problem Misconnection (1399)

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

Event Date 09/28/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.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 (b)(6) patient hospitalized for right knee prosthesis infection.The patient is infused on a midline, which had been placed on (b)(6).A non-occlusive dressing is placed over the midline due to a discharge bloody at the opening.The dressing is removed because the statlock is taken off.It is then found that the midline is emerged by 5 cm.During the repair of the dressing with the kit provided, difficulty to close the new statlock.The line came out 5 cm again during handling.

• Brand Name: STATLOCK IV SELECT LUER RETAINER SELECTPADS MICROBORE 6IN LUER LOCK
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12685371
• MDR Text Key: 278092895
• Report Number: 3006260740-2021-04490
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 00801741081842
• UDI-Public: (01)00801741081842
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K980994
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2021
• 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: IV0521CE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Age: 79 YR