MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SITE-RITE ULTRASOUND NEEDLE GUIDE KIT 18G; TRANSDUCER, ULTRASONIC, DIAGNOSTIC

Model Number N/A

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/17/2021

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of refn1907 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that a contamination of a white foreign material was found on the probe cover.There was no reported patient involvement.No other information was provided.

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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling.Based on a review of this information, the following was concluded: the complaint of a foreign material is confirmed but the exact source of the material remains unknown.One siterite needle guide kit was returned opened.The probe cover, ultrasound gel, and needle guides were returned wrapped within the drape.A white, solid material was noted on the surface of the probe cover.The material was spread out unevenly.The material was observed to be firm.A plastic tool was used to apply pressure to the white material and impressions were observed to be retained.The photos were forwarded to the manufacturing facility for further evaluation and the determination of the root cause remained unknown.No findings from a manufacturing review indicated a manufacturing/processing related cause.Possible contributing factors include deposition of the foreign material prior to or after kit packaging.Therefore, as the definitive root cause or source of this contamination could not be determined, the cause remains unknown.H3 other text : device evaluation findings are in the manufacturer's note.

Event Description

"it was reported that a contamination of a white foreign material was found on the probe cover.There was no reported patient involvement.No other information was provided.".

• Brand Name: SITE-RITE ULTRASOUND NEEDLE GUIDE KIT 18G
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12454096
• MDR Text Key: 270841957
• Report Number: 3006260740-2021-03753
• Device Sequence Number: 1
• Product Code: ITX
• UDI-Device Identifier: 00801741037818
• UDI-Public: (01)00801741037818
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K042445
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: 9001C0212
• Device Lot Number: REFN1907
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2021
• 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