MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ENCOR NEEDLE GUIDE INSERT; DISPOSABLE BIOPSY

Catalog Number	ENCFINSERT10G
Medical Device Problem Codes	Accessory Incompatible (1004); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/04/2023
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 return of the sample is pending.The investigation of the reported event is currently underway.(expiry date: 04/2024).Section a through f: the information provide 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 or Problem Description
It was reported that during a stereotactic breast biopsy procedure through normal density tissue, the needle guide was allegedly too tight and took so long to remove the needle.There was no reported patient injury.
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.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 accessory incompatible and difficult to remove issues 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: d4 (expiry date: 04/2024), g3, h6 (method).H11: h6 (result, conclusion).H11: section a through f: the information provide 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 or Problem Description
It was reported that during a stereotactic breast biopsy procedure through normal density tissue, the needle guide was allegedly too tight and took so long to remove the needle.There was no reported patient injury.
Event or Problem Description
It was reported that during a stereotactic breast biopsy procedure through normal density tissue, the needle guide was allegedly too tight and took so long to remove the needle.It was further reported that the needle guide was too small.There was no reported patient injury.
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: received one unsealed and twelve sealed encor needle guide inserts were returned for evaluation.Since, original sample was returned along with, the sealed lot samples; the returned sealed samples will not be evaluated.On visual evaluation, the needle guide insert appeared to be clean and flash was noted within the inner surface.There were no other visual anomalies noted on the device.On functional evaluation, the encor needle guide insert was loaded onto an in-house 10g encor probe needle.Resistance was noted when loading the insert onto the needle, and could not be completely loaded onto the needle.On dimensional observation, the inner diameter was measured and measurement was noted to be not within the acceptable range.Therefore, the investigation is confirmed for the reported accessory incompatible issue as the resistance was noted when loading & removing the insert from the needle and the inner diameter was measured and measurement was noted to be not within the acceptable range.And, the investigation is inconclusive for the reported difficult to remove issue as the condition of use cannot be replicated at the laboratory.The definitive root cause for the alleged accessory incompatible issue was determined to be a manufacturing issue.And, the definitive root cause for the alleged difficult to remove 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.The information provide 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 : see h10.

• Brand Name: ENCOR NEEDLE GUIDE INSERT
• Common Device Name: DISPOSABLE BIOPSY
• 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: 17866438
• Report Number: 2020394-2023-00781
• Device Sequence Number: 17630809
• Product Code: KNW
• UDI-Device Identifier: 00801741086465
• UDI-Public: (01)00801741086465
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K040842
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/05/2024

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 Catalogue Number: ENCFINSERT10G
• Device Lot Number: VTGR0233
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2023
• Supplement Date Received by Manufacturer: 11/28/2023; 02/05/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 11/30/2023; 02/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/06/2022
• 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 Sex: Female