MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. MAGNUM NEEDLE; BIOPSY INSTRUMENT

Model Number	MN1820
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: only one device was involved in this reportable event at the user facility.Additional unused lot samples from the same lot/product catalog number were returned from the customer for evaluation and investigation of this event.The original samples were not returned for evaluation, but three sealed lot bard magnum biopsy needles were returned for evaluation.Since, no original samples were returned; three lot samples were returned the one lot sample was opened and evaluated.On visual evaluation, the sample was sealed.It was noted that the stylet hub was from cavity 14 and the cannula hub was from cavity 14.There were no visual anomalies noted on the device.Further, functional testing was not performed due to the nature of the complaint.Upon dimensional observation, the notch thickness was measured, and the measurement was noted to be within specification.The reported event was unconfirmed for the evaluated lot sample, as there is no allegation was found.However, the investigation is inconclusive for the reported adverse event without identified device or use problem as the original devices were not returned for evaluation only sealed lot samples were returned.A definitive root cause for the alleged adverse event without identified device or use problem could not be determined based upon the provided information.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.H10: d4 (expiry date: 04/2025).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 : see h10.
Event or Problem Description
It was reported that during a prostate biopsy procedure through normal density tissue, the patient experienced bleeding.A coaxial needle was not used.The procedure was completed using another device.During the biopsy, a profuse rectorrhagia was unable to be controlled with a few minutes of compression of the prostate with the transducer, interrupting the procedure.The patient was transferred to the emergency department in stable condition but with active bleeding in the anal area.Urgent rectoscopy was performed in which several punctate lesions were visualized corresponding to the puncture sites, one with a clot.Two clips were placed there.The patient was kept under observation in stable condition.No new rectal bleeding appeared thus the patient was discharged after 24 hours.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe 85281
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16939198
• Report Number: 2020394-2023-00341
• Device Sequence Number: 6017790
• Product Code: FCG
• UDI-Device Identifier: 00801741084355
• UDI-Public: (01)00801741084355
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2023

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: MN1820
• Device Catalogue Number: MN1820
• Device Lot Number: REGS4197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male