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

Model Number MN1410

Device Problems Device Markings/Labelling Problem (2911); Material Twisted/Bent (2981)

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

Event Date 11/28/2021

Event Type  malfunction  

Event Description

It was reported that during a biopsy procedure, the length of the needle was allegedly not accurate from label.It was further reported that needle was bent.There was no reported patient injury.

Manufacturer Narrative

As the lot number for the device was provided, a review of the device history record is currently being performed.The device has not been returned to the manufacturer for evaluation.However, a photos were provided for review.The investigation of the reported event is currently underway.Expiry date: 09/2023.

Event Description

It was reported that during a biopsy procedure, the length of the needle was allegedly not accurate from label.It was further reported that needle was bent.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: three electronic photos were provided and reviewed.The first photo shows that the magnum needle in a package which is in primed position.The second photo shows product labeling which the product information was verified with tw.And the third photo shows the unpacked magnum needle which is different in size and also in primed position is kept next to a packed magnum needle.Based on the photo review the reported failures cannot be confirmed.Therefore, the investigation is inconclusive for the reported failure as the package was not sealed.A definitive root cause for the alleged device markings / labelling problem and material twisted / bent 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: 09/2023), 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.H3 other text : device not returned.

• 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: judy ludwig ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 13070819
• MDR Text Key: 282782515
• Report Number: 2020394-2021-02099
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084249
• UDI-Public: (01)00801741084249
• Combination Product (y/n): N
• Reporter Country Code: EG
• 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: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2021
• 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: REEX0619
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/04/2020
• 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