MAUDE Adverse Event Report: BARD ACCESS SYSTEMS STERILE ULTRASOUND PROBE COVER WITH GEL; ULTRASOUND TRANSDUCER AND ACCESSORIES

Catalog Number 9001C0197

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pleural Effusion (2010); Pneumonia (2011)

Event Date 06/21/2017

Event Type  Injury  

Manufacturer Narrative

The information provided by bard 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 bard.The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rexl0073 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported that potential contamination may have occurred upon ultrasound procedure using ultrasound gel provided in the product.The patient was admitted to hospital with severe multi lobar pneumonia and a large left sided pleural effusion.The pleural effusion drained under ultrasound guidance consisted burkholderia and streptococcus milleri species.The patient admitted to injecting morphine tablets mixed with tap water intravenously before becoming sick.The health care professional (hcp) commented on the possibility that injection of tap water by the patient may have contributed to this incident.The microbiologist tested the ultrasound gel and found no evidence of contamination.

• Brand Name: STERILE ULTRASOUND PROBE COVER WITH GEL
• Type of Device: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• Manufacturer Contact: teresa johnson ; 605 n. 5600 w.; salt lake city, UT 84116 ; 8015225435
• MDR Report Key: 6724703
• MDR Text Key: 80423364
• Report Number: 3006260740-2017-01087
• 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: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 9001C0197
• Device Lot Number: REXL0073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: MEROPENEM
• Patient Outcome(s): Hospitalization; Other; Required Intervention