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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL BREAST TISSUE MARKER IMPLANTABLE CLIP

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BARD PERIPHERAL VASCULAR, INC. ULTRACOR TWIRL BREAST TISSUE MARKER IMPLANTABLE CLIP Back to Search Results
Model Number UCTW17
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 05/03/2018
Event Type  malfunction  
Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer, but photos were provided. The lot number for the device was provided. The device history records are currently under review. The device has not been returned for evaluation. The investigation of the reported event is currently underway. (b)(6) 2017). 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 Description
It was reported that the needle of the breast tissue marker allegedly pierced through the packaging. There was no patient or user contact.
 
Manufacturer Narrative
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. The sample was not returned for evaluation. Photos were provided for review. Based on the photo review, the needle exposed through the package can be confirmed. It is unknown whether all sides of the packaging were sealed, as the provided photos did not capture a full image of the entire packaging. Although, the photo review concluded the needle to be exposed through the packaging, the overall investigation is inconclusive for the reported breach of sterile barrier, as it is unknown whether the packaging was sealed on all sides. Per the reported event details, no damage was noted to the shipment box. The devices are received by the msa at the facility. The msa unpacks the received devices, transports by hand to the ultrasound department, and stores the devices in a cabinet. The original device was not returned for evaluation however photos were provided for review. The photo review concluded that the needle was exposed through the packaging, however it is unknown whether all sides of the packaging were sealed as the provided photos did not capture a full image of the entire packaging. Therefore, the definitive root cause for the reported breach of sterility could not be determined based upon the provided information. It is unknown whether the transport or storage of the devices contributed to the reported event. Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate. (expiry date 10/2020).
 
Event Description
It was reported that the needle of the breast tissue marker allegedly pierced through the packaging. There was no patient or user contact.
 
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Brand NameULTRACOR TWIRL BREAST TISSUE MARKER
Type of DeviceIMPLANTABLE CLIP
Manufacturer (Section D)
BARD PERIPHERAL VASCULAR, INC.
1625 w 3rd st.
tempe AZ 85281
Manufacturer (Section G)
BARD SHANNON LIMITED
san geronimo industrial park
lot #1, road #3, km 79.7
humacao 00791
Manufacturer Contact
judith ludwig
1625 w 3rd st.
tempe, AZ 85281
4803032689
MDR Report Key7555170
MDR Text Key109624587
Report Number2020394-2018-00757
Device Sequence Number1
Product Code NEU
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K152510
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/28/2020
Device Model NumberUCTW17
Device Catalogue NumberUCTW17
Device Lot NumberHUBX2969
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/02/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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