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

Catalog Number	ENCFINSERT10G
Medical Device Problem Codes	Difficult To Position (1467); Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Visual inspection: the needle guide insert was returned clean.No breaks and/or cracks were identified.Functional/performance evaluation: the inner diameter (id) of the needle guide insert was measured and found to be 0.142".The returned needle guide insert was within specifications for a 12g needle insert instead of the 10g as the labeling stated.Medical records review: medical records were not provided; therefore, a review could not be performed.Image/photo review: photos/images were not provided; therefore, a review could not be performed.Conclusion: one encor needle guide insert was returned for evaluation.Pin gauges were used to determine the inner diameter of the returned insert.The investigation is confirmed for a device markings issue and for the reported difficulty inserting the probe through the insert, as the returned insert was measured to be a 12g needle guide insert instead of the supposed 10g needle guide insert as identified on the returned labeling.The returned sample was found to be within the specifications for a 12g needle guide insert, instead of the labeled 10g.Corrective action was completed and isolated the issue to the supplier of the injection molded components.The rap lists "inadequate line clearance" as a potential root cause for confirmed mix-ups.Labeling review: the current instructions for use (ifu) states: a sterile, disposable needle guide insert, model encfinsert-12g, encfinsert-10g or encfinsert- 7g, packaged and sold separately, is inserted into the needle guide to provide a sterile guide for the encor® tip.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during preparation for a stereotactic breast biopsy, the probe allegedly was unable to go through the needle guide insert to position for the procedure.Reportedly, another insert was able to perform the procedure.There was no reported patient contact.

• Brand Name: ENCOR NEEDLE GUIDE INSERT
• Common Device Name: BIOPSY INSTRUMENT
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w 3rd st.; tempe AZ 85281
• MDR Report Key: 6827338
• Report Number: 2020394-2017-01037
• Device Sequence Number: 19232634
• Product Code: GEI
• UDI-Device Identifier: 00801741086465
• UDI-Public: (01)00801741086465
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K042098
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/29/2017

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 Expiration Date: 03/30/2018
• Device Catalogue Number: ENCFINSERT10G
• Device Lot Number: VT16C0184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2017
• Initial Report FDA Received Date: 08/29/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 52 YR
• Patient Weight: 57