MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE~RITE PROBE COVER KIT WITH GEL (48 IN); TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number 9001C0197

Device Problem Defective Component (2292)

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

Event Date 05/27/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of reet3223 showed one other similar product complaint(s) from this lot number.The complaints for this lot number have been reported from the same facility in the australia.

Event Description

It was reported that two probe covers were noted to be really thin and split at the end of the probe during procedures.No other information was provided.This report addresses the first probe cover.

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 batch history, applicable previous investigation(s), applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of holes or splits in the probe covers was confirmed and appears to be supplier related.The products returned for evaluation were two probe cover kits with gel.The kits were received unopened and unused.The kits were labeled with the use by date of 2023-05-31 which had not been exceeded.The probe covers appeared unremarkable to gross visual examination.No holes, cuts, tears, rips, or perforations were visible in the material under gross visual examination.The seams appeared consistent along the length of the devices.The lengths and widths of the returned probe covers met the device specifications.The distal 12¿ of the probe covers were filled with water and observation was conducted, looking for leaks in the seams and/or materials.When sample 1 was tested, a small dripping leak was observed in the distal end, along the crease in the cover.When sample 2 was tested, a spraying leak was observed 2.8¿ from the distal end of the cover.As the devices were unopened prior to being evaluated, the cause is likely related to the materials or manufacturing process.Bd is working closely with manufacturing to prevent recurrence of the reported event.

Event Description

It was reported that two probe covers were noted to be really thin and split at the end of the probe during procedures.No other information was provided.This report addresses the first probe cover.

• Brand Name: SITE~RITE PROBE COVER KIT WITH GEL (48 IN)
• 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: kayla olsen ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12008612
• MDR Text Key: 256482265
• Report Number: 3006260740-2021-02305
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037801
• UDI-Public: (01)00801741037801
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9001C0197
• Device Catalogue Number: 9001C0197
• Device Lot Number: REET3223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2020
• 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