MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Defective Component (2292)

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

Event Date 08/19/2022

Event Type  malfunction  

Event Description

It was reported when the usg site rite 21g safety cover was positioned for picc placement, it was notice it has a hole.The safety cover has been discarded because patient in quarantined due to covid, and procedure was completed using a new device.(b)(6) 2022 information received.In which part of product was hole observed? at the proximal end, where we placed the probe, i noticed the hole because the gel that was on the probe leaked out of the cover.Was there any damage to its packaging? there was not.Was there any damage to patient? no, the hole was noticed when wearing the cape, being replaced immediately.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reft3407 showed no other similar product complaint(s) from this lot number.

• Brand Name: SITE~RITE ULTRASOUND SYSTEM NEEDLE GUIDE KIT (21G)
• Type of Device: TRANSDUCER, ULTRASONIC, DIAGNOSTIC
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 15459114
• MDR Text Key: 306185237
• Report Number: 3006260740-2022-03662
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037771
• UDI-Public: (01)00801741037771
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/13/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2024
• Device Model Number: N/A
• Device Catalogue Number: 900013B01
• Device Lot Number: REFT3407
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/05/2022
• Initial Date FDA Received: 09/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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