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

Model Number MN1410

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 05/03/2022

Event Type  malfunction  

Event Description

It was reported that prior to a biopsy procedure, the device was allegedly found mislabeled.There was no patient contact.

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 not been returned to the manufacturer for evaluation.However, photos were provided for review.The investigation of the reported event is currently underway.(expiration date: 10/2024).

Event Description

It was reported that prior to a biopsy procedure, the device was allegedly mislabeled.There was no patient contact.

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: the physical device was not returned for evaluation.Two electronic photos were provided for review.First photo shows the two labels where the information in both the labels were matching the product specifications.And it shows the two magnum label formats(i.E outside the box label and inside package label).Second photo shows the registration of the medical device under the reynosa manufacturing site.Per, the required documents mentioned in the labelling review, the provided label matches the specifications.Therefore, based on the photo review, the reported failure label issue could not be confirmed.And it was noted that the device is manufactured in us and packaged in mexico.Therefore, the investigation for the reported label issue is unconfirmed as the provided label met the specifications required.A definitive root cause for the alleged label issue 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: 10/2024), 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 prior to a biopsy procedure, the device was allegedly mislabeled.There was no patient contact.

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: the physical device was not returned for evaluation.Five electronic photos were provided.First photo shows the two labels where the information in both the labels were matching the product specifications.And it shows the two magnum label formats(i.E outside the box label and inside package label).Second photo shows the registration of the medical device under the reynosa manufacturing site.Third photo shows the box where the label is visible.Fourth photo shows the merchandise label stating made in usa format and it shows the current format that was printed in the label.Fifth photo shows the driver label where the specifications of the component is mentioned and the document number is printed at the bottom of the label.Per the required documents mentioned in the labelling review and the photos provided, specifications required have been met.Therefore, based on the photo review, the reported failure label issue could not be confirmed as all labels are printed based on the current format and it met all specifications mentioned in the document.And it was noted that the device is manufactured in us and packaged in mexico.Therefore, the investigation for the reported labelling issue is unconfirmed as the provided label met the specifications required.A definitive root cause for the alleged labelling issue 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: (expiration date: 10/2024).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 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: 14540088
• MDR Text Key: 292958848
• Report Number: 2020394-2022-00421
• Device Sequence Number: 1
• Product Code: FCG
• UDI-Device Identifier: 00801741084249
• UDI-Public: (01)00801741084249
• Combination Product (y/n): N
• Reporter Country Code: PE
• 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,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2022
• 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: REFY0743
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2022
• 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