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

Model Number 2016MSK

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/22/2023

Event Type  Injury  

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 provided, a review of the device history records is currently being performed.The return of the sample is pending.However, photos were provided for review.The investigation of the reported event is currently underway.H10: d4 expiration date: 10/2024.H11: section a through f ¿ the information provided by bd represents all 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 pending return.

Event Description

It was reported that during a biopsy procedure, the needle allegedly broken into two pieces in the patient's lumbar disc.It was further reported that the patient had to be taken from ct to fluro to have this removed with the help of a trauma surgeon to remove the pieces.There was no reported patient injury.

Event Description

It was reported that during a computed tomography guided lumbar disc biopsy procedure through normal density tissue, the needle allegedly broken into two pieces in the patient's lumbar disc.It was further reported that the inner stylet allegedly came out with the outer portion of the coaxial introducer.Furthermore, patient had to be taken from computed tomography to fluro with the help of a trauma surgeon to remove the pieces.Coaxial was used.Reportedly, the broken needle was removed by surgical cut.The patient is reported to be stable.

Manufacturer Narrative

H10: additional information was received, and the file was reassessed for reportability and determined to be reportable as serious injury.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 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.H10: d4 (expiration date: 10/2024).H11: section a through f ¿ the information provided by bd represents all 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.

Manufacturer Narrative

The manufacturing location was selected as unknown due to system limitations.The manufacturing location for the mission product is bd-santo domingo.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 needle inside the chamber where the needle was noted to be broken and it was noted to have residue.Second photo shows the trocar stylet inside the chamber where the needle was noted to be broken.Therefore, based on the photo review, the reported failure detachment can be confirmed.A definitive root cause for the alleged detachment 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.D4 (expiration date: 10/2024).H11: section a through f ¿ the information provided by bd represents all 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 computed tomography guided lumbar disc biopsy procedure through normal density tissue, the needle allegedly broken into two pieces in the patient's lumbar disc.It was further reported that the inner stylet allegedly came out with the outer portion of the coaxial introducer.Furthermore, patient had to be taken from computed tomography to fluro with the help of a trauma surgeon to remove the pieces.Coaxial was used.Reportedly, the broken needle was removed by surgical cut.The patient is reported to be stable.

• Brand Name: MISSION KIT
• Type of Device: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): UNKNOWN; BR
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 16768310
• MDR Text Key: 313569701
• Report Number: 2020394-2023-00263
• Device Sequence Number: 1
• Product Code: KNW
• UDI-Device Identifier: 00801741097096
• UDI-Public: (01)00801741097096
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171953
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2016MSK
• Device Catalogue Number: 2016MSK
• Device Lot Number: 0001442312
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/22/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White