MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR MRIPROBE TROCAR10G; BIOPSY INSTRUMENT

Model Number	ECPMR0110G
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that during a biopsy procedure, the device allegedly had foreign material on sample cup.It was further reported that the foreign material was removed and the needle was used.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number was not provided; however, the manufacturing process was reviewed.Based on the results of the manufacturing review, it was concluded that contamination on the complaint products could be related to the nature of parts and manufacturing process of probe products.The products have been 100% inspected to remove contamination however, additional operator training was conducted to ensure awareness and focusing on the product contamination in their operations.Investigation summary: the physical device was not returned for evaluation.One biohazard bag was received with an unknown substance/material.The material was inspected via microscopic imaging and appeared to be amber in color with a jelly like consistency, containing fibers within along with what appears to be blue flecks.The material was further inspected via ftir/sem analysis.The analysis concluded the returned material composition was consistent with pe (polyethylene, pet (polyethylene terephthalate), silicone, dispersant (such as drewsperse s-825), and 300 series stainless (such as 304 stainless) with some aluminum (ai) detected which may be the result of metal transfer as the material is not consistent with stainless.Although the ftir/sem analysis concluded material composition consistent with materials used in the build of this device, neither the physical device nor a photo identifying the alleged foreign material were provided; therefore the investigation is inconclusive.The returned material could potentially be a result of handling and usage by the end user or related to the nature of parts and manufacturing process of probe products.Based on the provided information, the foreign material like fuzz was found and removed from the device and unknown if the foreign material was potentially contaminated with any other materials prior to evaluation.A definitive root cause for the reported issue could not be determined.Labeling review: a review of product labeling documentation (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.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.H3 other text : device not returned.
Event or Problem Description
It was reported that during preparation for a biopsy procedure, foreign material like fuzz was allegedly found on sample cup.It was further reported that the foreign material was removed and the needle was used.There was no reported patient injury.

• Brand Name: ENCOR MRIPROBE TROCAR10G
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12357440
• Report Number: 2020394-2021-01494
• Device Sequence Number: 3936796
• Product Code: KNW
• UDI-Device Identifier: 00801741086304
• UDI-Public: (01)00801741086304
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K040842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2022

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
• Operator of Device: Health Professional
• Device Model Number: ECPMR0110G
• Device Catalogue Number: ECPMR0110G
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2021
• Supplement Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 03/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1