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

Catalog Number	9001C0197
Health Effect - Clinical Codes	Bacterial Infection (1735); Pleural Effusion (2010); Pneumonia (2011)
Date of Event	06/21/2017
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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
• Common Device Name: ULTRASOUND TRANSDUCER AND ACCESSORIES
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6724703
• Report Number: 3006260740-2017-01087
• Device Sequence Number: 10895601
• Product Code: ITX
• UDI-Device Identifier: 00801741037801
• UDI-Public: (01)00801741037801
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K042445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 9001C0197
• Device Lot Number: REXL0073
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEROPENEM
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention