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
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/28/2021
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STAND, INFUSION
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 12685371
• Report Number: 3006260740-2021-04490
• Device Sequence Number: 14379193
• Product Code: DYB
• UDI-Device Identifier: 00801741081842
• UDI-Public: (01)00801741081842
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K980994
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/05/2021

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 Model Number: N/A
• Device Catalogue Number: IV0521CE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/29/2021
• Initial Report FDA Received Date: 10/22/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 79 YR