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 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history records will be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiry date: 03/2024).

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.

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 it appeared there was a bend to sample notch.And it was further noted that the sample notch was bent backwards when positioned on flat surface.On dimensional observations, it was noted that the bend was out of specification limit.Functional evaluation was not done due to the condition of the device.Therefore, the investigation for the reported needle bent is confirmed as the bent was noted during visual evaluation and the bent was out of specification limit during dimensional observation.However, the investigation for the reported difficult to remove remains inconclusive as the functional testing was not performed due to the condition of the returned device.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.H10: d4(expiry date: 03/2024), g3, h6(method) h11: h6(result, conclusion) 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 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.

Manufacturer Narrative

10: 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.H10: g3.H11: d4(medical device lot), g1, h6 (method, result, conclusion).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 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

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.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 it appeared there was a bend to sample notch.And it was further noted that the sample notch was bent backwards when positioned on flat surface.On dimensional observations, it was noted that the bend was out of specification limit.Further functional testing was not performed due to the condition of the device.Therefore, the investigation for the reported needle bent is confirmed as the bent was noted during visual evaluation and the bent was out of specification limit during dimensional observation.However, the investigation for the reported difficult to remove remains inconclusive as the functional testing was not performed due to the condition of the returned device.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.H10: g3, h2, h6(method).H11: h6(result, conclusion).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 an ultrasound guided breast biopsy procedure through normal density tissue, the device needle was allegedly bent.It was further reported that the device was allegedly difficult to be removed.Coaxial needle was used.The procedure was completed using another device.There was no reported patient injury.

• 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: 13220252
• MDR Text Key: 283811390
• Report Number: 2020394-2021-02165
• 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,Followup,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/20/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/26/2021
• 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