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

Model Number MN1410

Device Problems Nonstandard Device (1420); Failure to Obtain Sample (2533); Device Markings/Labelling Problem (2911)

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

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation and a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 06/2024).

Event Description

It was reported that during a biopsy procedure, the device allegedly failed to obtain samples.It was further reported that the device allegedly had problem with the length of the needle.The procedure was completed using another device.There was no reported patient injury.

Manufacturer Narrative

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: one bard magnum biopsy needle was returned for evaluation.On visual evaluation, the device appeared to have blood residue throughout and the device was received with sample notch exposed condition.And it was noted that the stylet needle was not seated correctly on the hub.Due to the condition of the device and the nature of the complaint, functional testing was not performed.On dimensional observations, the cannula length was not found to be in the acceptable range.Therefore, the investigation for the identified non-standard device is confirmed as the cannula length was not in the acceptable range.However, the investigation for the reported device markings and labelling problem is kept as inconclusive as the identified issue may contributed to the reported issue.Therefore, the investigation for the reported failure to obtain sample is kept as inconclusive as the functional testing was not performed.One electronic photo was provided for review.Photo shows two blocks where the first block shows two magnum needle which were focused on the hubs (one is defective device and other is normal device).Second block shows the needle portion (i.E stylet) of the needles where the length of the stylet for the defective needle is longer than the normal needle which is kept along the needle.Therefore, based on the photo review, the reported failure failure to obtain sample and device markings/labelling problem could not be confirmed.However, based on the photo review, the identified non-standard device can be confirmed.Therefore ,the investigation for the reported failure to obtain samples and device markings/labelling problem is kept as inconclusive as there were no proper evident provided.However, the investigation for the identified non-standard device can be confirmed.A definitive root cause for the alleged failure to obtain samples and device markings/labelling problem and the identified non-standard device 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 (expiration date: 06/2024), g3, h6 (device, method).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.

Event Description

It was reported that during a biopsy procedure, the device allegedly failed to obtain samples.It was further reported that the device allegedly had problem with the length of the needle.The procedure was completed using another device.There was no reported patient injury.

• Brand Name: MAGNUM NEEDLE
• 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: 14011964
• MDR Text Key: 288659998
• Report Number: 2020394-2022-00256
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084249
• UDI-Public: (01)00801741084249
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MN1410
• Device Catalogue Number: MN1410
• Device Lot Number: REFV0382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2021
• 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