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

Model 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	05/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a biopsy procedure, the needle was allegedly difficult to be passed through the guide.It was further reported that the guide was allegedly difficult to be removed.It was also reported that the there was an asymmetric flange inside the guide which lugs and sits almost firmly over several parts of the needle.It was also reported that resistance was felt when pulling the flange off.Furthermore, after the guide was fitted, depending on the extent there was tightness around the barbs.Reportedly the flange/edge was completely clear and sharply defined and it was spread over approximately half the circle resulting in noise.There was no reported patient injury.
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.However, a photo was provided for review.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.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.Since an initial mdr was submitted, therefore, the file will remain assessed as a malfunction.H10: d4 (expiration date: 04/2024), g3 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.H3 other text : device pending return.
Event or Problem Description
It was reported that during a biopsy procedure, the needle was allegedly difficult to be passed through the guide.It was further reported that the guide was allegedly difficult to be removed.It was also reported that the there was an asymmetric flange inside the guide which lugs and sits almost firmly over several parts of the needle.It was also reported that resistance was felt when pulling the flange off.Furthermore, after the guide was fitted, depending on the extent there was tightness around the barbs.Reportedly the flange/edge was completely clear and sharply defined and it was spread over approximately half the circle resulting in noise.There was no reported patient injury.

• 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: 17037026
• Report Number: 2020394-2023-00386
• Device Sequence Number: 15195005
• Product Code: KNW
• UDI-Device Identifier: 00801741086465
• UDI-Public: (01)00801741086465
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2023

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: ENCFINSERT10G
• Device Catalogue Number: ENCFINSERT10G
• Device Lot Number: VTGR0233
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/05/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 06/01/2023
• Supplement Report FDA Received Date: 07/10/2023
• 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
• Patient Sex: Unknown