MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR BIO PROBE 7G VERT; BIOPSY INSTRUMENT

Model Number	ECP017GV
Medical Device Problem Codes	Unsealed Device Packaging (1444); Tear, Rip or Hole in Device Packaging (2385); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2021
Type of Reportable Event	Malfunction
Additional 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, photos were provided for review.The investigation of the reported event is currently underway.(expiry date: 04/2023).Device not returned.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device seal has broken.There was no patient contact.
Event or Problem Description
It was reported that prior to a biopsy procedure, the device seal has broken.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.Five photos were provided and reviewed.The first, second & fifth photos showed the two open cases of encor probes kept on a chair; one encor probe within the inner packaging also kept next to the open cases.Both the opened cases were damaged, torn and bent.The third & fourth photos shows that one inner product package extending out of one case with the user holding open the tyvek seal in one hand and the inner tray in the other hand, thus confirming an open seal.It is unknown how many inner product packages were open as the provided photos show one opened inner package.Based on the photo review, the reported packaging problem can be confirmed.Additionally, based on the photo review, unsealed device packaging can also be confirmed.Therefore, the investigation is confirmed for the reported packaging problem as the damage was noted to the outer carton.And the investigation is confirmed for the reported unsealed device packaging as the one encor probe inner packaging was noted to be unsealed.A definitive root cause for the alleged packaging problem and unsealed device packaging 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: 04/2023), g3, h6 (method).H11: h6 (device, 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.
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.Five photos provided were provided and reviewed.The first, second and fifth photos shows the two open cases of encor probes ; one encor probe within the inner packaging also kept next to the open cases.Both the opened cases were damaged, torn and bent.The third and fourth photos shows one inner product package extending out of one case with the user holding open the tyvek seal in one hand and the inner tray in the other hand, thus confirming an open seal.It is unknown how many inner product packages were open as the provided photos show one opened inner package.Based on the photo review, the reported packaging problem can be confirmed.Additionally, based on the photo review, unsealed device packaging can also be confirmed.Therefore, the investigation is confirmed for the reported packaging problem as the damage was noted to the outer carton.And the investigation is confirmed for the reported unsealed device packaging as the one encor probe inner packaging was noted to be unsealed.A definitive root cause for the alleged packaging problem and unsealed device packaging 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: b5, d4 (expiry date: 04/2023).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 prior to a biopsy procedure, the outer packaging box got damaged and the device seal has been broken.There was no patient contact.

• Brand Name: ENCOR BIO PROBE 7G VERT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• Manufacturer (Section G): INFUS MEDICAL (THAILAND); 706 moo 4; bangpoo ind estate; samutprakarn province 10280 ; TH 10280
• Manufacturer Contact: brett curtice ; 800 w. rio salado pkwy; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 12906228
• Report Number: 2020394-2021-02022
• Device Sequence Number: 17350711
• Product Code: KNW
• UDI-Device Identifier: 00801741086298
• UDI-Public: (01)00801741086298
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K051158
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/18/2022

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: ECP017GV
• Device Catalogue Number: ECP017GV
• Device Lot Number: VTFR0238
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/09/2022; 05/18/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/14/2022; 05/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2021
• 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 Sex: Unknown