MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 18" EXTENSION TUBE WITH CONNECTOR, STERILE; PVC EXTENSION TUBING

Catalog Number	4A4194
Medical Device Problem Code	Inadequate Instructions for Healthcare Professional (1319)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.
Event or Problem Description
It was reported that the packaging was labeled for (b)(4) but contained the brown colored latex tubing which coincides with (b)(4).
Event or Problem Description
It was reported that the packaging was labeled for ref# 4a4194 but contained the brown colored latex tubing which coincides with ref# 6a4194.
Additional Manufacturer Narrative
The reported event was unconfirmed.The visual evaluation of the returned sample noted 6 extension tubes in original unopened packaging.The packages were all labeled with a product catalog number of 4a4194 and were clear in color with an attached connector.According to product specifications for 4a4194, the extension tubing was within specification (pvc and clear in color).The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "4a4194 sterile: content is sterile unless package is opened or damaged.Single use".

• Brand Name: 18" EXTENSION TUBE WITH CONNECTOR, STERILE
• Common Device Name: PVC EXTENSION TUBING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8200602
• Report Number: 1018233-2018-06211
• Device Sequence Number: 13870786
• Product Code: FAQ
• UDI-Device Identifier: 00801741051562
• UDI-Public: (01)00801741051562
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/19/2019

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: Lay User/Patient
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 4A4194
• Device Lot Number: NGCV2806
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2018
• Initial Date Received by Manufacturer: 12/06/2018
• Supplement Date Received by Manufacturer: 03/28/2019
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 04/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1