MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED; WOUND DRAIN

Model Number	072223
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
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 hair was found when the package was opened.
Additional Manufacturer Narrative
The reported event was confirmed however the cause was unknown.One sample was confirmed to exhibit the reported failure.Visual evaluation of the returned sample noted one opened (with original packaging), unused silicone channel drain.Visual inspection of the sample noted that there was a large hair taped to the back packaging.This does not meet the specification as "no hair is permitted on the product.".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 as labelling could not have prevented the reported failure.Corrections: d, h.H11: section a through f - 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that foreign material like hair was found when the package was opened.

• Brand Name: SILICONE CHANNEL DRAIN WITH 3/16 IN. TROCAR, 15 FR., ROUND, 3/4 FLUTED
• Common Device Name: WOUND DRAIN
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11628653
• Report Number: 1018233-2021-01950
• Device Sequence Number: 3866551
• Product Code: GBX
• UDI-Device Identifier: 00801741049842
• UDI-Public: (01)00801741049842
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2021

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: 06/30/2025
• Device Model Number: 072223
• Device Catalogue Number: 072223
• Device Lot Number: NGET2285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 04/07/2021
• Supplement Report FDA Received Date: 09/22/2021
• 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