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

Catalog Number	UNK MISSION NEEDLE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Pneumothorax (2012); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H10: the manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.H10: as the lot number for the device was not provided, a review of the device history records could not be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.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 during a ct guided lung biopsy procedure, the patient allegedly suffered from pneumothorax.Coaxial was used.The procedure was completed using same device.It was further reported that no chest tube was placed at that time and pneumothorax was able to be resolved.The current status of the patient is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3, h6 (method) h11: d1, d4 (medical device catalogue number) 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.
Event or Problem Description
It was reported that during a computed tomographic guided lung biopsy procedure, the patient allegedly suffered from pneumothorax.A coaxial was used.The procedure was completed using same device.It was further reported that no chest tube was placed at that time and pneumothorax was able to be resolved.The current status of the patient is unknown.
Event or Problem Description
It was reported that during a computed tomographic guided lung biopsy procedure, the needle was unable to advance through the coaxial.The device and needle were removed and a second attempt to obtain the biopsy was done with a new device of a different lot number.During the procedure, the patient allegedly experienced a pneumothorax.No chest tube was placed at that time the physician was able to resolve the pneumothorax.A coaxial needle was used during the procedure.The procedure was successfully completed using another device.The device was returned for analysis.
Additional Manufacturer Narrative
H10: as it was unknown which device caused the pneumothorax; two complaints were opened.One complaint was opened for the device that allegedly had incompatibility issues and that event was reported to your firm via mfg report # 2020394-2024-00281.The second complaint was opened for the second device used during the biopsy procedure that had no alleged device problem but may have contributed to the pneumothorax and was reported to your firm via mfg report #2020394-2023-00639.H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as malfunction.H10: manufacturing review: a manufacturing review was not requested as the lot number reported is unknown.Investigation summary: the physical device was not returned for evaluation.No photos were provided for review.Therefore, the investigation is inconclusive for the reported failure as no objective evidence was provided for review.A definitive root cause for the alleged issue could not be determined based upon the provided information.Labeling review: as the reported event did not allege a labeling or use related issue, a labeling review is not required.H10: g3 h11: b1, b5, h1, h6 (patient) 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: MISSION NEEDLE
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): BARD SHANNON LIMITED -3005636544; san geronimo industrial park; lot #1, road #3, km 79.7; humacao PR 00791
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 17660282
• Report Number: 2020394-2023-00639
• Device Sequence Number: 6190304
• Product Code: KNW
• UDI-Device Identifier: 00801741097065
• UDI-Public: (01)00801741097065
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K171953
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: UNK MISSION NEEDLE
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/07/2023
• Supplement Date Received by Manufacturer: 01/11/2024; 02/27/2024
• Initial Report FDA Received Date: 08/31/2023
• Supplement Report FDA Received Date: 01/25/2024; 03/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown