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

Model Number	MN1416
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2022
Type of Reportable Event	Malfunction
Additional 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, a photo was provided for review.The investigation of the reported event is currently underway.(expiration date: 09/2024).
Event or Problem Description
It was reported that prior to a biopsy procedure, the hair was allegedly found on the package.There was no patient contact.
Additional 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 but two electronic photos were reviewed.The first photo shows a cannula hub within the packaging.However, a package seal cannot be determined.A hair strand is noted to be present next to the cannula hub.The second photo shows the label of the magnum needle.Provided label matches with the reported details lot number (refx3251) and catlog number (mn1416).While a hair strand can be noted next to the needle, a complete view of the packaging and package seal was not provided for complete evaluation.Therefore, based on the photo review foreign material in packaging cannot be confirmed.A definitive root cause for the alleged foreign material 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: 09/2024), g3, h6 (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 or Problem Description
It was reported that before receiving the product into their stock system, the hair was allegedly found on the package.There was no patient contact.

• Brand Name: MAGNUM NEEDLE
• Common Device Name: 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: 14302386
• Report Number: 2020394-2022-00354
• Device Sequence Number: 5224101
• Product Code: FCG
• UDI-Device Identifier: 00801741084263
• UDI-Public: (01)00801741084263
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K934370
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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
• Operator of Device: Health Professional
• Device Model Number: MN1416
• Device Catalogue Number: MN1416
• Device Lot Number: REFX3251
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 07/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/12/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Sex: Unknown