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

Model Number MN1413

Device Problems Difficult to Remove (1528); Material Twisted/Bent (2981)

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

Event Date 12/24/2021

Event Type  malfunction  

Manufacturer Narrative

As this malfunction is considered one event; only one mdr report will be submitted for the reported quantity affected of 13 for this event.As the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.

Event Description

It was reported that during an ultrasound guided breast biopsy through normal density tissue, the needle of the device was allegedly bent.It was further reported that the device was allegedly difficult to be removed.A coaxial needle was used.The procedure was completed by using another device.There was no reported patient injury.

Event Description

It was reported that during an ultrasound guided breast biopsy procedure through normal density tissue, the device needle allegedly bent.It was further reported that the device was allegedly difficult to removed.Coaxial needle was used.The procedure was completed by using another device.There was no reported patient injury.

Manufacturer Narrative

H10: as this malfunction is considered one event identified by the dealer; only one mdr report will be submitted for the reported quantity affected of thirteen for this event.Two lot numbers were provided (refv0321 and refr1982) with unclear information on the number of occurrences for each lot.Hence, d4(medical device lot number) has been updated as unknown.Additional unused lot samples of quantity 10 (five for refv0321 and five for refr1928) from the same lot/product catalog numbers were returned from the customer for evaluation and investigation of this event.H10: manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: the physical device was not returned for evaluation but ten lot samples (five for refv0321 and five for refr1928) were returned for evaluation.One sample from refv0321 and one sample from refr1928 were opened and evaluated.The needles were loaded into the in-house driver and functionally tested in a chicken breast.The devices were tested 10 times on the 22mm setting, and 10 times on the 15mm settings, for a total of 20 tests.The devices fired and collected a sample each time with no issues.On dimensional observations, the devices were within the specifications for both the needle bent and notch thickness evaluation.Therefore, the investigation for the reported needle bent and difficult to remove for the lot sample is unconfirmed as the devices were working in fine condition.However, the investigation for the reported needle bent and difficult to remove for the original sample is kept as inconclusive as the original sample was not returned for evaluation.A definitive root cause for the alleged needle bent and difficult to remove 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.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.

• Brand Name: MAGNUM
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 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: 13314725
• MDR Text Key: 284297106
• Report Number: 2020394-2022-00017
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084256
• UDI-Public: (01)00801741084256
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K934370
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/07/2022

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
• Device Operator: Health Professional
• Device Model Number: MN1413
• Device Catalogue Number: MN1413
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/24/2021
• Initial Date FDA Received: 01/21/2022
• Supplement Dates Manufacturer Received: 07/07/2022
• Supplement Dates FDA Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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