MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED; BARD SILICONE CHANNEL DRAIN

Model Number	072217
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/23/2020
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.
Event or Problem Description
It was reported that foreign material like a dust was found inside the package.
Event or Problem Description
It was reported that foreign material like a dust was found inside the package.
Additional Manufacturer Narrative
The reported event was confirmed as manufacturing-related.Visual inspection noted one wound drain was received in the unopened original packaging.Visual evaluation noted a black spec measuring 4.00 sq mm was found inside the sealed packaging, inside the packaging, but outside of the inner packaging.This fails to meet specifications as the product must be clean and free from oil or grease or loose foreign matter in excess of an aggregate total of 0.6mm² or 1/16in.In length.Although the reported event was confirmed, a root cause could not be determined.A potential root cause for this failure could be no follow up to production areas cleaning procedure.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.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: the actual/suspected device was inspected.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 10MM, FLAT, 3/4 FLUTED
• Common Device Name: BARD SILICONE CHANNEL DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 10718608
• Report Number: 1018233-2020-20324
• Device Sequence Number: 19598268
• Product Code: GBX
• UDI-Device Identifier: 00801741049828
• UDI-Public: (01)00801741049828
• 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: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/28/2021

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: 01/31/2025
• Device Model Number: 072217
• Device Catalogue Number: 072217
• Device Lot Number: NGEN4747
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 01/28/2021
• Initial Report FDA Received Date: 10/22/2020
• Supplement Report FDA Received Date: 02/23/2021
• 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