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

Model Number	121816
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/12/2021
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 device has been returned to the manufacturer for evaluation as well as photo was provided for review.The investigation of the reported event is currently underway.(expiry date: 11/2022).
Event or Problem Description
It was reported that prior to the biopsy procedure, the device allegedly self activated.The procedure was completed using another device.There was no patient contact.
Event or Problem Description
It was reported that prior to the biopsy procedure, the device allegedly self activated.The procedure was completed using another device.There was no patient contact.
Additional Manufacturer Narrative
H10: manufacturing review: a manufacturing review was not required as this is the only complaint reported to date for this product and lot.Investigation summary: one monopty disposable core biopsy instrument was returned for evaluation.During visual inspection, the sample appeared clean.The stylet and cannula were in their initial positions (not retracted).There were no visual anomalies noted on the device.Upon functional testing by twisting the rotational knob once, the cannula retracted and locked into place.The rotational knob was turned once more and the device self activated.The device was not able to be fully primed.Priming of the device was attempted again however when the rotational knob was turned the second time the device self activated.During microscopic evaluation, one of the stylet tangs was noted to be bowed inward.The measurement of the stylet tang width was not within the acceptable range.Based on the findings, the investigation is confirmed for the reported self activation issue.The definitive root cause could not be determined based upon available information.Labeling review: the review of the instructions for use, indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.H10: d4 (expiry date: 11/2022),g3, h6 (method).H11: h6 (result and 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 : see h10.

• Brand Name: MONOPTY
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 11918561
• Report Number: 2020394-2021-01149
• Device Sequence Number: 10974111
• Product Code: KNW
• UDI-Device Identifier: 00801741084645
• UDI-Public: (01)00801741084645
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K133948
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2021

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: 121816
• Device Catalogue Number: 121816
• Device Lot Number: REEZ0674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Received by Manufacturer: 05/12/2021
• Supplement Date Received by Manufacturer: 07/13/2021
• Initial Report FDA Received Date: 06/02/2021
• Supplement Report FDA Received Date: 07/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other