MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 WOUND DRAIN

Model Number	0070310
Medical Device Problem Code	Unclear Information (4052)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/28/2020
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.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.
Event or Problem Description
It was reported that the drain device was found not to be graduated after use.There is no black scale on the drain tube.Per additional information via email from (b)(4) on 23sep2020, there is no black scale on the surface of the drain.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted one silicone bulb evacuator was received with 2 drainage tubes.Visual evaluation noted that there were no markings on either of the drainage tubes.This fails to meet specifications as the markings should be neatly inked and must not get unpainted.The markings should have been on the drain per specifications.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be omitted operation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.
Event or Problem Description
It was reported that the drain device was found not to be graduated after use.There was no black scale on the drain tube.Per additional information via email from ibc on 23sep2020, there was no black scale on the surface of the drain.

• Brand Name: WOUND DRAIN
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 10623631
• Report Number: 1018233-2020-06326
• Device Sequence Number: 11483224
• Product Code: GBX
• UDI-Device Identifier: 00801741049460
• UDI-Public: (01)00801741049460
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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 Expiration Date: 06/30/2024
• Device Model Number: 0070310
• Device Catalogue Number: 0070310
• Device Lot Number: NGDT2486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Received by Manufacturer: 09/11/2020
• Supplement Date Received by Manufacturer: 01/13/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1